MAUDE Adverse Event Report: Spinal Kinetics M6-C; Artificial Cervical Disc

Model Number	CDL-637L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury

• Brand Name: M6-C
• Common Device Name: Artificial Cervical Disc
• Manufacturer (Section D): Spinal Kinetics; 501 mercury dr; sunnyvale CA 94085
• Manufacturer (Section G): Spinal Kinetics; 501 mercury dr; sunnyvale CA 94085
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 50875089
• Report Number: 3004987282-2026-00027
• Device Sequence Number: 13089820
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: Health Professional
• Device Model Number: CDL-637L
• Device Catalogue Number: CDL-637L
• Device Lot Number: 3376917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Sex: Unknown