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

Model Number 6L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neck Pain (2433)

Event Date 03/14/2023

Event Type  Injury  

Manufacturer Narrative

The build lhr for fg 0005-05, (b)(6), 1684675 was examined including the final inspection records and the in-process measurements.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.No alleged device failure or malfunction and was only removed due to facet arthropathy.The risk management files were reviewed and no new risks were identified.

Event Description

Information provided states that an m6-c artificial cervical disc was placed at c5/6 in 2021.The device was removed due to facet arthopothy and the need for a greater decompression at the index level.The patient had presented with 2 level symptoms resulting in the need for a fusion at c6/7 using interbody and plate.

Event Description

Information provided states that an m6-c artificial cervical disc was placed at c5/6 in 2021.The device was removed due to facet arthopothy and the need for a greater decompression at the index level.The patient had presented with 2 level symptoms resulting in the need for a fusion at c6/7 using interbody and plate.

Manufacturer Narrative

The build lhr for fg 0005-05 (b)(6) 1684675 was examined including the final inspection records and the in-process measurements.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.No alleged device failure or malfunction and was only removed due to facet arthropathy.The risk management files were reviewed and no new risks were identified.Based on the inspection of the retrieved m6-c, in conjunction with the clinical data, and the provided radiographic images, the device had not failed mechanically at the time of removal.The device was likely intact, as reported, with little to no in vivo damage visible to the sheath, fiber, and endplates.The core was not returned for inspection.Only one pre-revision image was available, which appeared to confirm that the device was still functional at the time of removal.The provided information appears to indicate that the device was likely contraindicated for the patient and the failure of this procedure was unrelated to device performance.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 16729055
• MDR Text Key: 313188624
• Report Number: 3004987282-2023-00012
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• 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,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6L
• Device Catalogue Number: CDL-627
• Device Lot Number: 1684675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2021
• 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: 58 YR
• Patient Sex: Female