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

Model Number	CDL-637L
Medical Device Problem Codes	Collapse (1099); Material Integrity Problem (2978); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Osteolysis (2377); Insufficient Information (4580)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested, device is being returned and investigation will be completed upon receipt.
Event or Problem Description
It was reported that the patient experienced disc failure underwent additional level fusion.C5-6 m6c in situ, removed and replaced with cage and new plate to cover c5-7 (c6-7 already fused).
Additional Manufacturer Narrative
Based on the inspection of the retrieved m6-c, in conjunction with the clinical data, and the provided information, the device showed clear evidence of in vivo mechanical failure.The device had collapsed, the endplates were polished and fractured, the sheath had cleaved, the majority of the fiber construct was not present, and the majority of the core was not present, consistent with abrasive contact between the endplates, confirmed by the radiographs and radiographic analysis.It was not possible to determine the sequelae of events that led to the removal of this device without further clinical and/or radiographic information; however, 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.Rmf 0003 rev 39 line 12.60.- device damaged/broken leading to surgical intervention with explantation.Rmf 0003 rev 39 line 12.45.- excessive height loss/disc collapse: < 1mm between endplates leading to surgical intervention, with explantation, involving patient with multiple cervical spinal implants.Rmf 0003 rev 39 line 12.73.4.- resorption or osteolysis, without infection/infected.Abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 39 line 12.75 - device explanted.
Event or Problem Description
It was reported that the patient experienced disc failure underwent additional level fusion.C5-6 m6c in situ, removed and replaced with cage and new plate to cover c5-7 (c6-7 already fused).

• 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: lourd shlaimon ; 501 mercury dr; sunnyvale, CA 94085
• MDR Report Key: 21829827
• Report Number: 3004987282-2025-00011
• Device Sequence Number: 11805898
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/01/2019
• Device Model Number: CDL-637L
• Device Catalogue Number: FG0031-14
• Device Lot Number: 1573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2014
• 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: Other
• Patient Age: 49 YR
• Patient Sex: Male