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

Model Number	420-PRO-08102500-S
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An expandable interbody cage was implanted and expanded as intended during a spinal procedure performed on (b)(6) 2025.No intraoperative complications were reported.At the 3-month postoperative visit, the surgeon identified a collapse of the cage.A revision surgery was performed to remove the collapsed cage and implant a new one.
Additional Manufacturer Narrative
The explant did not return for evaluation.Radiographs were provided which confirm the event of a collapsed cage at the inferior level.The lot number was not provided; therefore, a review of device history records cannot be performed.Based on the information provided, the root cause cannot be determined.Alphatec spine is submitting this report in compliance with fda regulations under 21 cfr 803.All relevant and available information has been 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.Warnings/cautions: potential risks identified with the use of these fusion devices, which may require additional surgery, include device component failure, loss of fixation, pseudarthrosis (i.E., non-union), fracture of the vertebra, neurological injury, and/or vascular or visceral injury.Possible adverse effects: initial or delayed loosening, bending, dislocation, and/or breakage of device components.Postoperative management: the surgeon should instruct the patient regarding the amount and time frame after surgery of any weight bearing activity.The increased risk of bending, dislocation, and/or breakage of the implanted devices, as well as an undesired surgical result are consequences of any type of early or excessive weight bearing, vibratory motion, falls, jolts or other movements preventing proper healing and/or fusion development.Immobilization should be considered in order to prevent bending, dislocation, or breakage of the implanted device in case of delayed, malunion, or nonunion of bone.Immobilization should continue until a complete bone fusion mass has developed and been confirmed.

• 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: 21945193
• Report Number: 2027467-2025-00075
• Device Sequence Number: 9056516
• Product Code: MAX
• UDI-Device Identifier: 00190376529813
• UDI-Public: (01)00190376529813
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K231438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 05/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420-PRO-08102500-S
• Device Catalogue Number: 420-PRO-08102500-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 05/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown