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

Model Number	420-PRO-07103000-S
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Unspecified Musculoskeletal problem (4535)
Date of Event	08/22/2025
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.A few months postoperatively, the surgeon identified that the cage had collapsed causing the vertebral body to also collapse causing the patient to experience pain.Revision surgery occurred to remove the cage.
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Correction: h3.Yes.H6.Investigation findings: 4256.Investigation conclusions: 61.Device evaluation: visual inspection of the returned cage revealed that the center post was displaced from its intended pocket within the distal end of the cage.In addition, the cross pin appears to be sheared, still within the center post slot.It is unknown whether the damage to the center post and cross pin occurred during implantation or removal.Labeling review: 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.Implanted devices should be revised or removed if bent, dislocated, or broken.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: 23076463
• Report Number: 2027467-2025-00219
• Device Sequence Number: 18576496
• Product Code: MAX
• UDI-Device Identifier: 00190376529721
• UDI-Public: (01)00190376529721(10)10146301
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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-07103000-S
• Device Catalogue Number: 420-PRO-07103000-S
• Device Lot Number: 10146301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown