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

Model Number 6MM LARGE LONG

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

A review of the lot history records for this device did not reveal any non-conformance to specification or deviations in procedure.Additional information has been requested.This device was implanted at a level above a thoracic fusion.In the us, the m6-c artificial cervical disc is indicated only in patients with disease at one level from c3-c7.The safety and effectiveness of the m6-c artificial cervical disc has not been established in patients with more than one cervical level requiring surgery.

Event Description

It was reported that the surgeon was revising a fusion due to a screw backing out.The m6-c was explanted due to an immunological reaction.The device was intact at the time of removal.

Manufacturer Narrative

A1: (b)(6).B4: (b)(6) 2021.G3: 22-aug-2021.H6 codes: medical device problem code: 2682 - patient-device incompatibility, type of investigation: 4114 - device not returned , investigation findings: 3221 - no findings available, investigation conclusions: 4315 - cause not established.H10: radiographic analysis was hindered by the poor quality of the provided images: however, mild radiolucency may have been present around the device.Limited information was provided; notably, no lab reports were provided.It was not possible to assess the potential role of surgical technique or patient selection based on the paucity of information provided.The risk management files were reviewed and no new risks were identified in the available reported information for this event that require any changes to the current fmea, risk analysis, or labeling.This report is made by the manufacturer without prejudice and does not imply an admission of liability for the incident or its consequences.As such, we are reporting this incident to err on the side of caution.Spinal kinetics' post-market surveillance procedures require multiple attempts to gain as much detailed information as possible regarding the reported event.No further investigation can be performed.Based on the limited information provided, the device did not malfunction and it was not possible to determine the cause of the complaint.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 94085
• MDR Report Key: 10964638
• MDR Text Key: 220168152
• Report Number: 3004987282-2020-00056
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: 6MM LARGE LONG
• Device Catalogue Number: CDL-637L
• Device Lot Number: 1284856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 08/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 105