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

Model Number	CDM-635L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Granuloma (1876); Osteolysis (2377)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No additional information has been provided at this time.Device did not return for investigation.No images were provided for review.If new information is provided, a follow up report will be submitted.
Event or Problem Description
It was reported there was a revision of a cdm-635l due to osteolysis and according to histological findings a polyethylene caused granuloma.

• 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: 24643571
• Report Number: 3004987282-2026-00006
• Device Sequence Number: 9786194
• Product Code: MJO
• UDI-Device Identifier: 00812388030025
• UDI-Public: 00812388030025
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: CDM-635L
• Device Catalogue Number: FG0031-10
• Device Lot Number: 1632147
• 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: 02/23/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2021
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 54 KG