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 Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior lumbar interbody fusion (alif) procedure, the graft bolt snapped in half during insertion.
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Correction: h3.Yes.H6.Investigation findings: 3252.Investigation conclusions: 61.Device evaluation: the graft bolt fragment was sheared through the proximal-most fenestration ~14.8 mm from the head of the graft bolt.Additionally, a portion of the shank thread major had been peeled away.The root cause is likely a result of excessive insertion torque.A review of device history records showed no manufacturing or processing related irregularities.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.Possible adverse effects: possible adverse effects include: initial or delayed loosening, bending, dislocation, and/or breakage of device components.

• 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: 21721471
• Report Number: 2027467-2025-00037
• Device Sequence Number: 17109351
• Product Code: OVD
• UDI-Device Identifier: 00190376369990
• UDI-Public: (01)00190376369990(10)TO02394
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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
• Device Lot Number: TO02394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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