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

Model Number	CDL-637L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rmf 0003 rev 39 line 15 - failure to relieve symptoms including unresolved pain.Rmf 0003 rev 39 line 12.75 - device explanted.
Event or Problem Description
It was reported that there was a removal of mc6 from patient today by dr due to persistent neck pain.Dr was able to remove implant whole with only limited damage to inner sheath due to drill.Disc looks in good condition and no signs of osteolysis.
Additional Manufacturer Narrative
Rmf 0003 rev 39 line 15 - failure to relieve symptoms including unresolved pain.Rmf 0003 rev 39 line 12.75 - device explanted.Based on the inspection of the retrieved m6-c compiled in the present report, in the absence of clinical data, radiographs, or radiographic analysis, the cause of this event was unclear.While some in vivo damage to the fiber construct was noted, gross mechanical failure was not evident.Destructive analysis is necessary to examine the fiber construct and the core.It is unknown if infection was present.Therefore, the failure of this procedure and the removal of this device was not clear; however, this device had likely not failed at the time of removal.
Event or Problem Description
It was reported that there was a removal of mc6 from patient today by dr due to persistent neck pain.Dr was able to remove implant whole with only limited damage to inner sheath due to drill.Disc looks in good condition and no signs of osteolysis.

• 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: 20592490
• Report Number: 3004987282-2024-00043
• Device Sequence Number: 18378505
• 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 Implanted Year: 2019
• 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): 12/03/2024

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: 08/01/2023
• Device Model Number: CDL-637L
• Device Catalogue Number: FG0031-14
• Device Lot Number: 10338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2018
• 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: 50 YR
• Patient Sex: Male