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

Model Number	801-200-50
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the prongs broke off the sleeve.No patient involvement reported.
Additional Manufacturer Narrative
The device did not return for evaluation.The lot number was not provided; therefore, a review of the device history record could not be conducted.Based on information provided, a definitive root cause could not be determined.Alphatec spine, inc.Is submitting this report in compliance with fda regulations under 21 cfr 803.All relevant and available information was included to the best of our knowledge at the time of this submission.Any fields left blank reflect information that was not known or not provided.Should additional details become available, a supplemental report will be submitted accordingly.

• Brand Name: IDENTITI II LIF 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 ; 7603586777
• MDR Report Key: 25524572
• Report Number: 2027467-2026-00126
• Device Sequence Number: 5547389
• Product Code: MAX
• UDI-Device Identifier: 00190376694382
• UDI-Public: (01)00190376694382
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K242364
• 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): 06/16/2026

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: 801-200-50
• Device Catalogue Number: 801-200-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown