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

Model Number	325-07103010
Medical Device Problem Codes	Collapse (1099); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is in the process of being return for evaluation.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
On (b)(6) 2024 a patient underwent a lumbar intervertebral body fusion procedure.At the 1 month postoperative visit, radiograph images reveal that the expandable cage has collapsed and migrated posteriorly.The patient received revision surgery on (b)(6) 2025 to remove the collapsed cage.
Additional Manufacturer Narrative
Correction: d4.Primary udi: (b)(4).D9.Yes, returned to manufacturer 02/24/2025.H3.Yes.H6.Type of investigation: 10, 3331, 4112.Investigation findings: 3253.Investigation conclusions: 4301.Additional information: d4.Lot #: ap02839.H4.11/01/2024.Device evaluation: the explant was received in a partially open state.No physical damage to implant components was observed aside from minor wear on surfaces intended to slide past each other during implantation and expansion.Some foreign matter (possibly graft material left over from cleaning) was lodged within the internal cage components preventing it from fully expanding or collapsing.After removing the foreign material, the implant was easily able to be actuated open and closed with very little torque applied to the drive screw via a t15 driver.The spacer collapsed after being implanted and expanded then migrated from the disk space in which it was placed.The root cause is likely not enough frictional drag between internal drive screw threads and the external center post threads.Review of device history records showed no manufacturing or processing related irregularities.Labeling review: warnings/cautions/precautions: 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 CCX 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: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 21414828
• Report Number: 2027467-2025-00013
• Device Sequence Number: 9312046
• Product Code: MAX
• UDI-Device Identifier: 00190376533001
• UDI-Public: (01)00190376533001
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K232504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 325-07103010
• Device Catalogue Number: 325-07103010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/23/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1065-2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown