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

Model Number	420-PRO-07103000-S
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant remains in situ.Radiographic imaging was provided confirming the event.Review of the device history record (dhr) confirms that implant met all dimensional and inspection requirements at the time of manufacture, with no nonconformances identified.There is no evidence to suggest that manufacturing-related issues contributed to the reported complaint.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.
Event or Problem Description
Around 11 months postoperatively, radiographic imagining revealed a collapsed expandable cage.The patient is asymptomatic, and there are no plans for revision surgery.

• Brand Name: CALIBRATE NANOTEC PSX
• 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: 25659130
• Report Number: 2027467-2026-00132
• Device Sequence Number: 13375075
• Product Code: MAX
• UDI-Device Identifier: 00190376529721
• UDI-Public: (01)00190376529721(10)9697301
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/29/2026

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: 420-PRO-07103000-S
• Device Catalogue Number: 420-PRO-07103000-S
• Device Lot Number: 9697301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2024
• 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 Age: 48 YR
• Patient Sex: Unknown