MAUDE Adverse Event Report: TITAN SPINE INC. ADAPTIX INTERBODY SYSTEM WITH TITAN NANOLOCK SURFACE TECHNOLOGY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	84332407
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding an implant used for tlif therapy.It was reported that the superior set screw on the right side of the patient was cross-threaded when broke off.This allowed the rod to move freely within the screw head.This lack of proper compression allowed for the cage to subside.Patient outcome was that surgeon extracted the tlif cage and then did an olif at the corresponding level with a divergence-l cage and a divergence plate and screws.The tlif cage was removed and then did an olif at the same level.The cage subsided posteriorly into the patients spinal column.No neurological damage occurred to the patient.

• Brand Name: ADAPTIX INTERBODY SYSTEM WITH TITAN NANOLOCK SURFACE TECHNOLOGY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): TITAN SPINE INC.; mequon research center; 6140a west executive drive; mequon WI 53092
• MDR Report Key: 11731170
• Report Number: 3006340236-2021-00009
• Device Sequence Number: 11817204
• Product Code: MAX
• UDI-Device Identifier: 00763000202866
• UDI-Public: 00763000202866
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 84332407
• Device Catalogue Number: 84332407
• Device Lot Number: TM0126900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/27/2021
• 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