Patients With an M6-C Artificial Cervical Disc May Face Osteolysis, Bone Loss, and Revision Surgery
Impact Attorneys is investigating potential claims involving the Orthofix and Spinal Kinetics M6-C Artificial Cervical Disc. Patients who received an M6-C implant and later developed osteolysis, progressive bone loss, worsening neck pain, neurological symptoms, implant failure, or the need for revision surgery may have legal options.
Impact Attorneys has prepared a products liability complaint on behalf of a California patient who received an M6-C disc at the C6-C7 level. The complaint alleges that polyethylene wear debris from the device caused an inflammatory response and progressive destruction of bone surrounding the implant. It further alleges that important safety information, foreign warnings, the discontinuation of the product line, and available alternatives were not properly disclosed before surgery.
If you were later diagnosed with osteolysis, bone loss, implant failure, or were told you may need revision surgery, Impact Attorneys can review the circumstances of your case.
M6-C Artificial Cervical Disc Case Overview
Key information regarding the M6-C Artificial Cervical Disc, its manufacturer, reported safety concerns, and current product status.
What Is the M6-C Artificial Cervical Disc?
The M6-C is an artificial disc designed to replace a damaged natural disc in the cervical spine, which is the portion of the spine located in the neck. Unlike cervical fusion, artificial disc replacement is intended to preserve movement at the treated spinal level.
The device was designed to imitate the movement and compressibility of a natural cervical disc. It was marketed outside the United States before receiving FDA approval for single level use in the United States in February 2019.
The M6-C is considered a Class III medical device. This category includes implantable devices subject to FDA premarket approval and continuing postmarket requirements.
M6-C Device Components
- Polycarbonate urethane polymer core
- Woven polyethylene fiber annulus
- Polymer sheath surrounding the internal structure
- Titanium endplates securing the implant to adjacent vertebrae
What Is the Alleged Problem With the M6-C Disc?
The complaint prepared by Impact Attorneys alleges that components of the M6-C can release microscopic polyethylene particles as the device wears over time.
These particles may enter the tissue surrounding the implant and trigger an inflammatory reaction. Immune cells attempt to remove the debris, but the inflammatory process may also destroy healthy bone around the device. This type of bone destruction is known as periprosthetic osteolysis.
Osteolysis can progressively weaken or destroy the vertebral bone supporting the artificial disc. Depending on the severity and location of the bone loss, the implant may become unstable or require surgical removal.
Studies Have Reported M6-C Osteolysis and Revision Surgery
The complaint cites multiple peer reviewed studies and case reports concerning M6-C wear, osteolysis, implant failure, and revision surgery.
2022 M6-C Revision Study
A prospective study involving 53 M6-C patients reported that 18 patients had undergone revision surgery for wear induced osteolysis after an average follow up period of approximately 67 months.
The researchers reported evidence of polyethylene wear debris and concluded that the device sheath intended to contain that debris had not been effective in the patients requiring revision.
2024 CT Imaging Study
A separate study examining 50 M6-C implants after an average follow up period of approximately 8.1 years reported osteolysis in 44 percent of implants, high grade heterotopic ossification in 34 percent, and complete implant failure in 12 percent.
2025 Revision Outcome Study
A follow up study reported that 19 of 53 M6-C patients, approximately 35.9 percent, required revision surgery because of osteolysis.
Revision surgery produced significant improvement in neck pain. However, improvements in arm pain and neck related disability did not reach the study's clinically meaningful thresholds. The researchers emphasized the importance of early detection and individualized revision strategies.
FDA MAUDE Reports Involving the M6-C
The complaint states that a search of the FDA Manufacturer and User Facility Device Experience database identified 460 adverse event reports involving the M6-C between February 2019 and July 2026.
According to the complaint, 429 of those reports had been received on or before July 1, 2025.
The complaint also cites a peer reviewed analysis of cervical artificial disc reports submitted to MAUDE. That analysis reportedly identified 162 osteolysis events involving cervical artificial discs, with 138 associated with the M6-C.
International M6-C Warnings and Regulatory Actions
The complaint describes a series of international labeling changes, warnings, monitoring recommendations, product restrictions, and other regulatory developments involving the M6-C.
Australian Hazard Alert
Australia's Therapeutic Goods Administration initiated a Product Defect Correction and Implant Hazard Alert. Updated information addressed the potential consequences of periprosthetic osteolysis and recommended routine long term clinical and radiographic monitoring.
United Kingdom Instructions Updated
The complaint states that the United Kingdom Instructions for Use were updated to include additional osteolysis precautions and patient monitoring recommendations.
Orthofix Discontinues the M6 Product Lines
Orthofix announced the worldwide discontinuation of the M6-C and M6-L product lines. Orthofix stated that the decision was related to resource allocation and was not driven by clinical performance.
Australian Registration Canceled
The Australian registration for the M6-C was canceled effective May 14, 2025.
Additional Australian Product Alert
Australian regulators initiated an additional Product Correction and Product Alert that narrowed certain indications and again recommended long term monitoring of implanted patients.
United Kingdom Product Alert
Orthofix issued an Urgent Product Alert Communication in the United Kingdom addressing osteolysis and long term clinical and radiographic monitoring.
United Kingdom Patient Monitoring Guidance
United Kingdom regulators directed healthcare providers to identify and contact M6-C patients for active monitoring, including annual cervical X-rays and additional CT or MRI imaging when appropriate.
Possible Symptoms of M6-C Osteolysis or Device Failure
Patients with an M6-C implant should speak with a qualified medical provider about new, recurring, or worsening symptoms.
- Increasing or recurring neck pain
- Pain traveling from the neck into the shoulder, arm, or hand
- Numbness or pins and needles in the arm or hand
- Weakness or clumsiness in the hands or arms
- Electric shock sensations when moving the neck
- Difficulty walking or maintaining balance
- Weakness or loss of coordination in the legs
- Symptoms similar to those experienced before the original surgery
Impact Attorneys' M6-C Products Liability Lawsuit
On August 25, 2026, Impact Attorneys filed a lawsuit in California Superior Court on behalf of an individual who received an M6-C Artificial Cervical Disc.
The lawsuit was filed against Orthofix, related entities, and the medical professionals involved in implanting the device.
The lawsuit involves allegations concerning the M6-C Artificial Cervical Disc and injuries allegedly associated with the device.
That matter is ongoing.
Who May Have an M6-C Artificial Disc Claim?
Receiving an M6-C implant does not automatically establish a legal claim. Each case requires an individual review of the implant, medical records, warnings, imaging, symptoms, and resulting damages.
- You received an M6-C Artificial Cervical Disc
- You were later diagnosed with osteolysis or cervical bone loss
- Imaging shows deterioration of bone surrounding the implant
- Your implant loosened, moved, collapsed, or failed
- You developed new or worsening neck pain
- You developed arm pain, numbness, tingling, or weakness
- You developed walking or balance problems
- Your doctor recommended M6-C removal or revision surgery
- You underwent cervical fusion after removal of the M6-C
- You were not informed about reported M6-C safety concerns
- You were not informed that the M6 product line had been discontinued
- You were not adequately informed about available alternatives
What Records Should M6-C Patients Preserve?
Documentation can be important when evaluating an M6-C claim. Patients should preserve available medical, implant, imaging, employment, and financial records related to their surgery and subsequent treatment.
- Implant identification card
- Original operative report
- Hospital and surgery center records
- Product labels and implant stickers
- Device model and serial number
- Preoperative and postoperative imaging
- X-rays, CT scans, and MRI scans
- Revision surgery recommendations
- Medical bills and insurance records
- Documentation of lost income
Preserving an Explanted Device
If an M6-C is removed during revision surgery, the explanted device may become important physical evidence.
Patients considering litigation should speak with their attorney regarding preservation of the device before revision surgery whenever possible.
Potential Compensation in an M6-C Lawsuit
The compensation available in an M6-C case depends on the individual circumstances, applicable law, medical evidence, and the parties responsible for the injury.
- Past and future medical expenses
- Diagnostic imaging and continuing surveillance
- Revision surgery and hospitalization costs
- Rehabilitation and physical therapy
- Lost wages
- Reduced future earning capacity
- Physical pain and suffering
- Emotional distress and anxiety
- Loss of mobility or physical function
- Loss of enjoyment of life
- Permanent impairment
- Loss of consortium suffered by a spouse
Punitive damages may also be available when permitted by applicable law and supported by the evidence.
How Impact Attorneys Investigates M6-C Claims
Medical device litigation can require analysis of medical records, imaging, implant identification information, regulatory history, adverse event reports, scientific literature, and manufacturer communications.
- Confirming that the implanted device was an M6-C
- Obtaining operative reports and implant records
- Reviewing CT scans and other diagnostic imaging
- Documenting the progression of osteolysis or bone loss
- Evaluating the need for revision surgery and future care
- Investigating the warnings provided before surgery
- Reviewing foreign safety notices and monitoring recommendations
- Examining FDA adverse event reports
- Preserving an explanted M6-C when available
- Consulting qualified medical and technical experts
- Identifying potentially responsible parties
- Calculating medical expenses and economic losses
Speak With an M6-C Artificial Cervical Disc Attorney
If you received an Orthofix or Spinal Kinetics M6-C Artificial Cervical Disc and were later diagnosed with osteolysis, bone loss, implant failure, neurological problems, or the need for revision surgery, Impact Attorneys can investigate your potential claim.
Call today for a free and confidential consultation. There are no attorney fees unless we obtain a recovery for you.
M6-C Artificial Cervical Disc Lawsuit FAQs
Has the M6-C Artificial Cervical Disc Been Recalled?
As of the August 25, 2026 complaint prepared by Impact Attorneys, the complaint alleges that the FDA had not issued a formal United States recall, safety communication, or field action concerning the M6-C. Orthofix announced the worldwide discontinuation of the M6-C and M6-L product lines in February 2025. A product discontinuation is not the same as an FDA recall.
What Is Osteolysis?
Osteolysis is the destruction or loss of bone. The complaint alleges that polyethylene particles released from the M6-C may cause an inflammatory response that destroys bone surrounding the implant.
Can M6-C Osteolysis Occur Without Symptoms?
Yes. Medical and regulatory materials cited in the complaint describe both symptomatic and asymptomatic osteolysis. Patients should discuss appropriate monitoring with a qualified medical provider.
How Is M6-C Osteolysis Diagnosed?
Medical providers may use X-rays, CT scans, MRI scans, physical examinations, and symptom history. The complaint and safety materials emphasize that CT imaging may be particularly important when osteolysis is suspected.
Does Every M6-C Patient Need Revision Surgery?
No. Treatment depends on the amount of bone loss, implant condition, symptoms, neurological findings, spinal stability, and the patient's medical circumstances. Treatment decisions should be made by qualified medical professionals.
How Can I Determine Whether I Received an M6-C?
Your implant card, operative report, hospital records, implant stickers, billing records, or surgeon records may identify the device. These records may list Spinal Kinetics, Orthofix, M6-C, a catalog number, or a serial number.
Is the Impact Attorneys M6-C Case a Class Action?
The complaint prepared on behalf of Shaun and Julia Cyrkin is an individual products liability and medical negligence action. It is not pleaded as a class action. Other patients may have separate claims based on their own injuries and circumstances.
How Long Do I Have to File an M6-C Lawsuit?
Filing deadlines depend on factors including the jurisdiction, implantation date, when symptoms began, when the injury was discovered, and which defendants may be responsible. Patients who believe they may have a claim should speak with an attorney promptly.
How Much Does an M6-C Case Review Cost?
The initial consultation with Impact Attorneys is free. Qualifying cases may be handled on a contingency fee basis, meaning there are no attorney fees unless the firm obtains a recovery.