MAUDE Adverse Event Report: ALPHATEC SPINE, INC. CALIBRATE NANOTEC PSX INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	420-PRO-09142500-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cage has not returned for evaluation as it remains in siu.Radiograph images were provided which confirm the event of a fractured cage.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.
Event or Problem Description
At the 6-week postoperative visit, radiographic imaging revealed a fracture of the expandable cage.Upon retrospective review of the 2-week postoperative radiographs, the fracture was also visible.The patient remains asymptomatic, and there are no plans for revision surgery.

• Brand Name: CALIBRATE NANOTEC PSX 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: 22350251
• Report Number: 2027467-2025-00153
• Device Sequence Number: 20033599
• Product Code: MAX
• UDI-Device Identifier: 00190376529363
• UDI-Public: (01)00190376529363
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K231438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/27/2025

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: 420-PRO-09142500-S
• Device Catalogue Number: 420-PRO-09142500-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/27/2025
• 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