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

Model Number	420-PRO-09103000-S
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At the 6-month postoperative visit, radiograph images revealed an expandable cage collapse.The patient remains asymptomatic, and no revision is planned at this time.
Additional Manufacturer Narrative
The implant remains in the patient, and a radiograph image was provided, which confirmed the complaint.A review of the device history records revealed no manufacturing or processing-related irregularities.The implants were manufactured and released in full compliance with design specifications.The root cause could not be determined.Alphatec spine is submitting this report to comply with fda regulations 21 cfr 803.Reasonable efforts have been made to include all available relevant information.Any fields left blank were unknown at the time of this submission.A supplemental report will be submitted if additional information becomes available.

• 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: 21777860
• Report Number: 2027467-2025-00045
• Device Sequence Number: 18290928
• Product Code: MAX
• UDI-Device Identifier: 00190376529929
• UDI-Public: (01)00190376529929(10)9624504
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K231438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/04/2025

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-09103000-S
• Device Catalogue Number: 420-PRO-09103000-S
• Device Lot Number: 9624504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 04/04/2025
• 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