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

Catalog Number	CDL-737L
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device related to this incident was returned for evaluation.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 device met the m6-c product specification including the axial stiffness and flexural resistance specifications.A review of the risk management files revealed no new risks associated with the device.Rmf 0003 rev 36 line 15 - failure to relieve symptoms including unresolved pain rmf 0003 rev 36 line 12.35.- subsidence leading to surgical/major intervention, with explantation, involving patient with multiple cervical spinal implants rmf 0003 rev 36 line 12.75 - device explanted.
Event or Problem Description
Information provided states that patient had m6-c implanted at c5/6 in (b)(6) 2019.Patient experienced a fall in mid 2022.The images showed subsidence of the device into the c6 vertebra and non-union of the fusion at the c6/7 level.Patient experienced pain in his right parascapular area and shoulder.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury drive; sunnyvale 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale 94085
• MDR Report Key: 17595270
• Report Number: 3004987282-2023-00050
• Device Sequence Number: 12369782
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2023

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: 11/30/2024
• Device Catalogue Number: CDL-737L
• Device Lot Number: 1392767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2019
• 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 Age: 40 YR
• Patient Sex: Male
• Patient Weight: 122 KG