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

Model Number	CDL-637L
Medical Device Problem Codes	Collapse (1099); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device was explanted.No further information is available.
Additional Manufacturer Narrative
The device involved has not yet been retured for investigation.Risk management files were reviewed and no new risks were identified.Rmf 0003 rev 38 line 12.75 - device explanted.
Additional Manufacturer Narrative
Based on the inspection of the retrieved m6-c, the device had failed mechanically at the time of removal, at approximately 8 years post-op.The endplates were in contact with evidence of in vivo polishing that had resulted in endplate fracture.The sheath and core were not provided, and the majority of the fiber construct was not present.Damage to the endplates indicated that the polymeric components were likely heavily damaged in vivo.Without interim radiographs, it was not possible to determine the sequelae of events that contributed to this failure.Further, with no clinical information, histopathology, or microbiology, it is unknown if infection was present and/or contributed to the removal of this device.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 38 line 12.75 - device explanted.
Event or Problem Description
Device was explanted.No further information is available.

• 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: ehab esmail ; 501 mercury dr; sunnyvale, CA 94085
• MDR Report Key: 19032975
• Report Number: 3004987282-2024-00009
• Device Sequence Number: 12517563
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• 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 Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: 10/25/2018
• Device Model Number: CDL-637L
• Device Catalogue Number: FG0031-14
• Device Lot Number: 1131
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2013
• 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 Sex: Unknown