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

Model Number	CDL-737L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that surgery was performed to remove one defective m6-c that was implanted 2 years ago on (b)(6) 2021.
Additional Manufacturer Narrative
Additional information along with the device return has been requested to complete the investigation.
Additional Manufacturer Narrative
Based on the inspection of the retrieved m6-c, in conjunction with the clinical data and image provided, it is unlikely that the device had failed mechanically at the time of removal.The device remained grossly intact, but there was no evidence of in vivo contact between the endplates or device collapse.Destructive analysis, including removal of the sheath, is necessary to further inspect the integrity of the fiber construct and the core, to determine if mechanical failure of the fiber construct and/or core had occurred.Although tissue samples were taken for microbiological analysis due to suspected infection, no lab results were provided.It is therefore while it is likely that infection was present, it cannot be confirmed that infection played a role in the failure of this procedure and the observed osteolysis.Rmf 0003 rev 39 line 12.58.- infection, infected abscess or infected cyst (not involving resorption or osteolysis), leading to surgical/major intervention with explantation.Rmf 0003 rev 39 line 12.75 - device explanted.
Event or Problem Description
It was reported that surgery was performed to remove one defective m6-c that was implanted 2 years ago on (b)(6) 2021.

• Brand Name: M6 CERVICAL
• 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: avinash thite ; 501 mercury dr; sunnyvale, CA 94085
• MDR Report Key: 20748570
• Report Number: 3004987282-2024-00046
• Device Sequence Number: 20904880
• Product Code: MJO
• UDI-Device Identifier: 00812388030087
• UDI-Public: 00812388030087
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: 03/01/2024
• Device Model Number: CDL-737L
• Device Catalogue Number: FG0031-15
• Device Lot Number: 1285627
• 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: 11/07/2021
• Supplement Date Received by Manufacturer: 11/07/2021
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2019
• 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: Other
• Patient Sex: Male