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

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

Patient Problem Paraplegia (2448)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that it appears to the surgeon that a bony fragment moved to the spinal canal some weeks or months after implantation, leading to the paraplegia.The device and additional information has been requested.Without a lot number, the device history records review could not be completed.

Event Description

A patient who underwent m6-c implantation in (b)(6) 2019 had to be revised after paraplegia.Surgeon assumes that a bony fragment pushed into the spinal canal.The segment was revised with a cage.The paraplegia resolved and the patient is doing well.

Manufacturer Narrative

The segment was revised with a cage.Post-revision the patient is doing well, and the paraplegia was eliminated completely.No radiographs were provided thus a radiographic assessment could not be performed.Limited information was provided; notably, no pre-operative or post-operative radiographs were provided.It was not possible to assess the potential role of surgical technique or patient selection based on the provided information.No serial or lot number has been provided, therefore, a review of the lot history records for this device could not be performed.The device was not returned, thus device examination could not be performed.It cannot be said for certain what caused the bony fragment to move to the spinal canal.

• 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: 8881371
• MDR Text Key: 153958326
• Report Number: 3004987282-2019-00031
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention