MAUDE Adverse Event Report: ALPHATEC SPINE, INC. IDENTITI POROUS TI INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	120-08093010-S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant did not return for evaluation as it remains in situ.Photographs were not provided; therefore, the complaint cannot be confirmed.The lot number was not provided; therefore, a review of device history records cannot be performed.Alphatec spine is submitting this report to comply with the fda regulations 21 cfr 803.Alphatec spine has made reasonable efforts to provide as much relevant information as available.Any field that is left blank was not known at the time of this submission.If additional information is provided, a supplemental report will be submitted.
Event or Problem Description
A patient underwent a spinal procedure on (b)(6) 2024.Approximately two and a half months postoperatively, radiographic imaging revealed that the rod on the right side of the construct had completely disengaged from the tulip head, and the interbody implant had rotated within the disc space.During revision surgery, exposure of the original construct revealed all set screws were intact and secure on the rod except for the right l4 screw.Although the set screw remained seated within the tulip head, the rod had migrated out of position.Both rods were subsequently removed and replaced, along with the screws at l4 and l2.All set screws were also removed and replaced.Prior to final tightening, the interbody implant was repositioned.This report 2 of 2.

• Brand Name: IDENTITI POROUS TI INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 21939650
• Report Number: 2027467-2025-00108
• Device Sequence Number: 9056335
• Product Code: MAX
• UDI-Device Identifier: 00190376193670
• UDI-Public: (01)00190376193670
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: 120-08093010-S
• Device Catalogue Number: 120-08093010-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female