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

Model Number	84332409
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
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 a patient with pre-operative diagnosis for lumbar spinal canal stenosis.Plif therapy was performed at l4/5.It was reported that during the postoperative follow-up it was revealed that the cage was backed out.The cage has protruded about 5 mm posteriorly from the posterior wall.There was no patient symptom & the patient was under observation in hospital.There are no plans for additional surgery at this time.

• 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; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE, INC.; mequon research center 6140a; mequon WI 53092
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13091281
• Report Number: 3006340236-2021-00031
• Device Sequence Number: 19357419
• Product Code: MAX
• UDI-Device Identifier: 00763000202880
• UDI-Public: 00763000202880
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 84332409
• Device Catalogue Number: 84332409
• Device Lot Number: TM0129297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/27/2021
• Date Device Manufactured: 11/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female