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

Model Number 6MM LARGE LONG

Device Problems Material Rupture (1546); Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

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 the m6-c was explanted due to pain.

Manufacturer Narrative

While there appeared to be resorption/osteolysis present and the device was explanted, based on the limited information provided, it was not possible to ascertain the relationship between these factors.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale, ca
• MDR Report Key: 10210354
• MDR Text Key: 196913582
• Report Number: 3004987282-2020-00021
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Model Number: 6MM LARGE LONG
• Device Catalogue Number: CDL-637L
• Device Lot Number: 5361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 63