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

Catalog Number CDL-737L

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 12/05/2023

Event Type  Injury  

Event Description

Information provided states that patient had m6-c artificial cervical disc implanted at level c6/7 in (b)(6) 2018.The patient recently began experiencing radicular pain resulting in the removal of the disc.The surgeon performed a corpectomy and fusion.

Manufacturer Narrative

The device has been received for analysis.

• Brand Name: M6-C
• Type of Device: 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: 18441530
• MDR Text Key: 331863445
• Report Number: 3004987282-2023-00069
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00812388030087
• UDI-Public: 00812388030087
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: CDL-737L
• Device Lot Number: 9908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male