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

Catalog Number	3110-3110-N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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®
• Common Device Name: IMPLANT
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr.; suite a; mequon WI 53092
• MDR Report Key: 8474499
• Report Number: 3006340236-2019-00003
• Device Sequence Number: 19200938
• Product Code: MAX
• UDI-Device Identifier: 00191375013419
• UDI-Public: 00191375013419
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K141953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR