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

Catalog Number	CDL-637L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Numbness (2415); Neck Pain (2433); Paresthesia (4421)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved has been received and an investigation is underway.The risk management files were reviewed and no new risks were identified.Rmf 0003 rev 38 line 12.32.- subsidence leading to surgical/major intervention, with explantation, involving patient with only a single level m6-c.Rmf 0003 rev 38 line 16 - dysesthesia or numbness paresthesia.Rmf 0003 rev 38 line 12.73.4.- resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 38 line 15 - failure to relieve symptoms including unresolved pain.
Event or Problem Description
Information provided states that an m6-c was implanted in 2017 at c5/6.The device was explanted in (b)(6) 2023 due to patient experienced neck pain, numbness in left arm, tingling into fingers and headaches.X-rays revealed lysis and subsidence.The vetrebral body above the implant was soft and unable to take acdf screw.Status of patient is standard post-op and soft collar.

• 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: 18179386
• Report Number: 3004987282-2023-00063
• Device Sequence Number: 7611361
• 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: 2017
• 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): 11/20/2023

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
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: CDL-637L
• Device Lot Number: 7612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2017
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 74 KG