Mobi-C Lawsuit Claims Cervical Disc Failure Caused Spinal Cord Injury, Resulting in Quadriplegia

Lawsuit alleges Mobi-C device failures were not properly reported to regulators, limiting doctors’ ability to assess safety risks.

A Texas Marine Corps veteran has filed a lawsuit claiming that a defective Mobi-C artificial cervical disc that was implanted in his spine failed, leaving him permanently paralyzed and dependent on others for daily care.

The complaint (PDF) was brought by Tyler Gleaves in Delaware Superior Court on December 11, naming the Mobi-C’s manufacturer, Highridge Medical LLC, formerly Zimmer Biomet Spine Inc., as the defendant.

The Mobi-C artificial disc is designed to replace damaged cervical discs in the neck, and marketed to relieve pain while preserving natural spinal motion in patients suffering from degenerative disc disease.

Originally developed by LDR Spine, the device was introduced internationally in 2004 and later acquired by Zimmer Biomet, whose spine division is now known as Highridge Medical. The Mobi-C received U.S. Food and Drug Administration (FDA) approval in 2013 for both one- and two-level cervical disc replacement, and has since been implanted in tens of thousands of patients.

According to the lawsuit, the device relies on a plastic core made of ultra-high-molecular-weight polyethylene positioned between metal spinal plates, a design that Gleaves alleges can catastrophically fail when FDA-approved manufacturing, sterilization or packaging standards are not followed.

Mobi-C Device Failure Allegations Raised in Lawsuit

According to the complaint, Gleaves underwent cervical disc replacement surgery in December 2017, during which a Mobi-C artificial disc was implanted at the C6–C7 level of his spine. He initially experienced improvement and was able to resume an active lifestyle.

However, the filing states that on September 30, 2023, the device fractured and migrated backward into the spinal canal, compressing Gleaves’ spinal cord and necessitating emergency surgery. 

Surgeons reportedly confirmed that the device’s ultra-high-molecular-weight polyethylene core, the plastic component designed to absorb motion and stress between metal plates, had broken. The failure allegedly resulted in a complete spinal cord injury at the C6 level.

As a result, Gleaves claims he is now quadriplegic, with loss of motor function below his chest and limited use of his hands.

The lawsuit alleges the failure occurred during normal physiological use, without trauma, misuse or unusual activity that would explain the fracture. Instead, Gleaves contends the device was defective when it left the manufacturer due to problems in how the polyethylene core was made, sterilized and packaged.

According to the complaint, the plastic insert was weakened by deviations from FDA-approved manufacturing processes. The lawsuit describes how improper gamma-radiation sterilization, inadequate control of oxidation, and failures in packaging designed to limit oxygen exposure can degrade polyethylene over time. These conditions allegedly caused the core to become brittle and more prone to cracking, even under routine spinal loads the device was designed to withstand.

The filing further alleges that required quality controls were not properly followed, allowing the polyethylene component to deteriorate during manufacturing and storage before implantation. As a result, the lawsuit claims the implant fractured prematurely, triggering the catastrophic failure inside Gleaves’ spine.

Mobi-C Manufacturing and Reporting Oversights 

The lawsuit cites prior FDA inspections of Highridge manufacturing facilities that allegedly identified repeated quality-system violations, including deficiencies in sterilization validation, environmental monitoring, and corrective and preventive action procedures.

According to the complaint, regulators questioned whether the company had effectively corrected those problems, noting continued violations during later inspections. Gleaves alleges these unresolved issues may have contributed to defects in the Mobi-C device implanted in his spine.

The filing also claims Highridge made changes to manufacturing, sterilization and packaging processes without submitting required premarket approval supplements to the FDA. Federal regulations require manufacturers to notify regulators of changes that could affect a device’s safety or effectiveness, but the lawsuit alleges those steps were not taken, leaving physicians and patients unaware of increased risks.

In addition, the complaint accuses Highridge of systematically underreporting Mobi-C device failures to the FDA, failing to submit required adverse-event reports, and closing investigations without conducting root-cause analyses. The lawsuit alleges that even Gleaves’ own 2023 device failure had not been reported as of the filing date, preventing regulators and surgeons from accurately assessing the device’s true safety profile.

“Defendant knowingly reported incorrect information to the Food and Drug Administration (‘FDA’)  or knowingly failed to report complete information to the FDA, physicians and consumers regarding the failure rate of the Device.  Defendant’s conduct was grossly negligent, wanton, willful and reckless with a conscious disregard of the rights of others.”

— Tyler Gleaves v. Highridge Medical LLC

Gleaves brings claims of strict liability, negligence and failure to warn, alleging the device was adulterated under federal law and unreasonably dangerous when it left the manufacturer’s control. He is seeking compensatory and punitive damages for medical expenses, pain and suffering, permanent disability, loss of income and other losses related to the injury.

The lawsuit also claims that recipients nationwide may have suffered similar injuries linked to the Mobi-C device, and that additional litigation could follow as more cases are reviewed.

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