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

Model Number	84332410
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2021
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 healthcare provider (hcp) via a manufacturer representative regarding a patient having tlif at l5-s1 s pinal therapy.It was reported that the cage subsided posteriorly and removed posteriorly.Patient is stable.Patient had cage removed posteriorly and then under went an olif at that level to replace the tlif cage.A revision surgery was needed for this surgery, surgeon took cage out and performed an alif on this patient.First cage subsided on (b)(6) 2021.Second cage subsided on (b)(6) 2021.There was no patient complication/ symptoms as a result of this event.

• Brand Name: ADAPTIX INTERBODY SYSTEM WITH TITAN NANOLOCK SURFACE TECHNOLOGY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): TITAN SPINE, INC.; mequon research center; 6140a west executive drive; mequon WI 53092
• MDR Report Key: 12272758
• Report Number: 3006340236-2021-00020
• Device Sequence Number: 19551042
• Product Code: MAX
• UDI-Device Identifier: 00763000202897
• UDI-Public: 00763000202897
• 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): 08/04/2021

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: 84332410
• Device Catalogue Number: 84332410
• Device Lot Number: TM0126840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/04/2021
• 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