MAUDE Adverse Event Report: ALPHATEC SPINE, INC. IDENTITI ALIF STANDALONE INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	232-10-85-300
Medical Device Problem Codes	Device Damaged by Another Device (2915); Damaged Thread (4075)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explants have not yet been returned for evaluation, although their return is anticipated.Due to the absence of a provided lot number, a review of the device history records could not be performed.As a result, the root cause cannot be determined at this time based on the available information.This report is being submitted in compliance with the requirements outlined in 21 cfr 803.Any fields left blank are due to the unavailability of relevant information at the time of submission.
Event or Problem Description
During an anterior lumbar interbody fusion (alif) procedure, a graft bolt was being inserted into the spacer, and minimal resistance was expected as the bolt head threads engaged.However, the bolt appeared to pass through the cage without properly locking.Radiographic imaging showed that the distal threaded portion of the bolt had gone through the cage, potentially breaching the spinal canal.The bolt and spacer were subsequently removed and replaced with new hardware.
Additional Manufacturer Narrative
D4.Lot# to04249.Udi:(b)(4).D9.Yes.H6.Investigation findings: 4248.Investigation conclusion: 22.H11.Device evaluation a review of the device history record for the identiti alif standalone graft bolt was conducted.The implant met all dimensional specifications at the time of manufacturing and passed quality control incoming inspection requirements.There is no evidence that the manufacturing process may have contributed to the failure mode.Visual inspection of the explanted graft bolt observed noticeable wear, including removal of anodization, along the major diameter of the threads along the shank and head.In addition, the threads along the head of the graft bolt were visibly deformed and flattened.While the root cause of this failure cannot be definitively confirmed, the observed damage is consistent with effects typically associated with off-axis insertion, such as non-concentric placement or a shallow-angle trajectory.Labeling review- "warnings/cautions/precautions: care should be taken in performing screw hole preparation to facilitate a proper graft bolt insertion trajectory and implantation.Confirm under fluoroscopy that the graft bolt insertion angle is as close as possible to a 40° trajectory.A shallow or incorrect graft bolt trajectory may result in encroachment of the spacer and lead to graft bolt breakage.".

• Brand Name: IDENTITI ALIF STANDALONE INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, 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: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 21668204
• Report Number: 2027467-2025-00052
• Device Sequence Number: 20877949
• Product Code: OVD
• UDI-Device Identifier: 00190376369990
• UDI-Public: (01)00190376369990
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K203742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: 232-10-85-300
• Device Catalogue Number: 232-10-85-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 76 KG