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

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Revision surgery occurred (b)(6) 2013.Exact date of revision surgery was not provided.Without a lot number, the device history records review could not be completed.Additional information and the return of the device has been requested.

Event Description

It was reported that an m6-c was explanted.It is unknown if the device malfunctioned.

Manufacturer Narrative

G1: mr.(b)(6).G2: distributor/importer.G3: 07-apr-2021.G6: follow-up # 1.H2: additional information.Manufacturer narrative: it was reported to spinal kinetics that m6-c was explanted.Limited information was provided; notably, no pre-operative, and post-operative, interim, or flexion/extension radiographs were provided.It was not possible to assess the potential role of surgical technique 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.No microbiology or pathology reports were provided.In summary, the explanted device, radiographic imaging, surgical reports or lab reports have not been provided.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
• MDR Report Key: 10451298
• MDR Text Key: 204341300
• Report Number: 3004987282-2020-00074
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR