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

Catalog Number CDL-637L

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The build lhr for 1842868 (b)(6) was examined including the final inspection records and the in-process measurements.There was no ncmr associated with this lot.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk management files were review and no new risks were identified.Rmf 0003 rev 38 line 12.75 - device explanted.It was reported that an m6 artificial disc was explanted and it was noted that the proper procedure for this patient was and acdf.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.

Event Description

Information provided states that patient had m6-c implanted at unknown level on (b)(6), 2023.The proper procedure for this patient was to be an acdf and a tdr (m6) has proven to be ineffective.No other information has been provided.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERFICAL 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: 18253295
• MDR Text Key: 329554282
• Report Number: 3004987282-2023-00065
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CDL-637L
• Device Lot Number: 1842868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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 Age: 52 YR
• Patient Sex: Male