MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON® TO NANOLOCK®; IMPLANT

Catalog Number 3110-3110-N

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the subject device had migrated post-operatively, leading to a revision surgery.Films were provided from immediately post-op and from the three month follow-up, where the device migration was discovered.There was no permanent impairment to patient and the device was explanted successfully on (b)(6) 2019.Titan spine's cmo was contacted to review the films provided.They noted that the device did not appear to be placed deep enough into the disc space at the time of original surgery.The selected device may have been too large/long, and a shorter device may have been a better choice to prevent migration post operatively.The returned subject device was inspected by titan spine, and determined to be within specifications for form, fit and function.

Event Description

The complainant alleged that the subject device migrated posteriorly, leading to a revision surgery.Initial surgery: (b)(6) 2018, revision surgery: (b)(6) 2019.

• Brand Name: ENDOSKELETON® TO NANOLOCK®
• Type of Device: IMPLANT
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr.; suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE; 6140 w. executive dr.; suite a; mequon WI 53092
• Manufacturer Contact: quinn lyster ; 6140 w. executive dr.; suite a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 8474499
• MDR Text Key: 140651488
• Report Number: 3006340236-2019-00003
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00191375013419
• UDI-Public: 00191375013419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2021
• Device Catalogue Number: 3110-3110-N
• Device Lot Number: TM0013471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2016
• 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): Required Intervention
• Patient Age: 77 YR