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 Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent an anterior lumbar interbody fusion (alif) at the l4-l5 level.During the procedure, no hole preparation was performed prior to screw insertion.While inserting the first graft bolt into the interbody spacer, the insertion angle was too shallow, resulting in bolt breakage.The broken bolt was removed, and the spacer was repositioned.A second attempt to place a graft bolt also resulted in breakage; however, the fractured bolt maintained adequate bony purchase and was left in place, along with the lateral screws.The procedure was completed without further complications, and the patient is currently doing well postoperatively.This is report 2 of 2.
Additional Manufacturer Narrative
The bolt has not returned for evaluation.Photographs were not provided.A review of the device history records could not be performed as the identifying lot number was not provided.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.Labeling review: note: proper trajectory and implantation of the graft bolt is faciliated by hole preparation using the trephine punch.Caution: 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: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 22377671
• Report Number: 2027467-2025-00161
• Device Sequence Number: 8091718
• Product Code: OVD
• UDI-Device Identifier: 00190376369990
• UDI-Public: (01)00190376369990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/01/2025

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: 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: 06/03/2025
• Initial Report FDA Received Date: 07/01/2025
• 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
• Patient Sex: Unknown