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

Model Number	CDL-637L
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a 44 y/o female patient had an m6 cage removed as she had developed osteolysis.Device has not returned for investigation.Once the device returns and investigation will be performed.
Event or Problem Description
It was reported a 44 year old femal patient had an m6 cage removed as they had developed osteolysis.
Event or Problem Description
It was reported a 44 year old femal patient had an m6 cage removed as they had developed osteolysis.
Additional Manufacturer Narrative
Based on the inspection of the retrieved m6-c compiled in the present report, in conjunction with the clinical data provided, it is likely that in vivo mechanical failure had occurred.Further destructive analysis, including inspection of the inner surfaces of the endplates and the inner fiber construct layer would be necessary to confirm this.However, the severe damage to the core suggests the endplates were likely in contact.It is unknown if infection was suspected or inflammation was observed; however, the stated reason for removal was osteolysis.In vivo damage to the polymeric components likely contributed to the reported osteolysis.Due to the extent of the extraction damage and lack of additional clinical and radiographic information, the sequelae of events that contributed to the removal of this device is unclear, though mechanical failure was evident.The build lhr was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with this lot.The devices met the m6-c product specification including the axial stiffness and flexural resistance specifications.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury dr; sunnyvale 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury dr; sunnyvale 94085
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 24315572
• Report Number: 3004987282-2026-00005
• Device Sequence Number: 14865382
• Product Code: MJO
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CDL-637L
• Device Catalogue Number: FG0031-14
• Device Lot Number: 1401620
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• 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: 44 YR
• Patient Sex: Female