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

Catalog Number	CDM-625
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Pain (1994); Dizziness (2194); Numbness (2415)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this incident was not provided for evaluation.The lhr for 3751 for (b)(6) was examined including the final inspection records and the in-process measurements.There were no ncmrs associated with this lot.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk management files were reviewed and no new risks were identified.Rmf 0003 rev 38 line 16 - dysesthesia or numbness paresthesia.Rmf 0003 rev 38 line 15 - failure to relieve symptoms including unresolved pain.Rmf 0004 rev 24 line 9.77 - device explanted.
Event or Problem Description
Information provided states that patient had m6-c implanted at c6/7 level in 2016.Patient experienced pain, numbness, dizziness and tension.The device was explanted in (b)(6) 2023 due to clinical symptoms.The device was not intact at the time of removal.
Additional Manufacturer Narrative
It was reported that an m6-c was explanted due to neck and back pain, left arm numbness, dizziness and tension.Radiographic images were not provided for review.Microbiology/pathology reports and results were also not provided.The device was not returned and therefore examination of the explant could not be completed, therefore it is not possible to determine the cause of the reported failure for this product experience.The build lhr was examined for sn: (b)(6) ln: 4040, including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with this lot.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk management files were reviewed and no new risks were identified.Rmf 0003 rev 38 line 16 - dysesthesia or numbness paresthesia.Rmf 0003 rev 38 line 15 - failure to relieve symptoms including unresolved pain.Rmf 0004 rev 24 line 9.77 - device explanted.
Event or Problem Description
Information provided states that patient has m6-c implanted at c6/7 level in 2016.Patient experienced pain, numbness, dissiness and tension.The device was explanted in (b)(6) 2023 due to clinical symptoms.The device was not intact at the time of removal.This report serves as an update regarding a typo in the original submission of the part number and sn of the device.

• 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: james stephens ; 501 mercury dr.; sunnyvale, CA 94085
• MDR Report Key: 18253313
• Report Number: 3004987282-2023-00066
• Device Sequence Number: 15098503
• Product Code: MJO
• UDI-Device Identifier: 00812388030018
• UDI-Public: 00812388030018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/10/2020
• Device Catalogue Number: CDM-625
• Device Lot Number: 4040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2023
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2015
• 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: 58 YR
• Patient Sex: Female