MAUDE Adverse Event Report: SPINAL KINETICS M6-C ARTIFICIAL CERVICAL DISC

Model Number	CDL-627
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested, once the surgery to remove the device has been done, a follow up report will be submitted as new information is gathered and the investigation is completed.
Event or Problem Description
Study subject (b)(6) was treated in the m6-c 1-level ide on (b)(6) 2015 and continued in the post-approval study (pas) to the final 10 year follow up visit on (b)(6) 2025.During the 10 year follow-up visit, the patient reported experiencing increased pain (reported pain as 7/10) and tension with radiculopathy down his right shoulder.Neurological exam is normal.Imaging showed complete collapse of the disc implant with the core dislocated (dislocation is anteriorly but location of core is to be confirmed by ct scan to be obtained in the next couple of weeks.Removal of the device is to be scheduled at the end of (b)(6) 2025.Collapse c5-6.
Additional Manufacturer Narrative
Based on the inspection of the retrieved m6-c compiled in the, in conjunction with the clinical data, and the provided information, the device showed evidence of mechanical failure.A loss of height and osteolysis was noted in the radiographs, the sheath was heavily damaged, there was evidence of in vivo contact between the endplates, and the fiber and core were not found at the time of removal.Cystic changes and radiolucency were noted as early as five years and were observed to have progressed by seven years, when an mva that resulted in neck pain occurred.Radiographic observations at the 5-, 7-, and 10-year post-op timepoints indicate that loss of height, radiolucency, and osteolysis were progressive, supporting the conclusion that the mechanical failure of the device was also progressive, though the mva may have exacerbated conditions and been a contributing factor to the failure of this device.
Event or Problem Description
Study subject (b)(6) was treated in the m6-c 1-level ide on (b)(6) 2015 and continued in the post-approval study (pas) to the final 10 year follow up visit on (b)(6) 2025.During the 10 year follow-up visit, the patient reported experiencing increased pain (reported pain as 7/10) and tension with radiculopathy down his right shoulder.Neurological exam is normal.Imaging showed complete collapse of the disc implant with the core dislocated (dislocation is anteriorly but location of core is to be confirmed by ct scan to be obtained in the next couple of weeks.Removal of the device is to be scheduled at the end of (b)(6) 2025.Collapse c5-6.

• Brand Name: M6-C ARTIFICIAL CERVICAL DISC
• Common Device Name: M6-C
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: yobana sanchez ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 22716477
• Report Number: 3004987282-2025-00018
• Device Sequence Number: 18544597
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CDL-627
• Device Lot Number: 1828173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male