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

Model Number	325-07103015
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a patient underwent a lumbar intervertebral body fusion procedure.Radiographs taken during the 6-month postoperative visit indicate a slight loss of cage height.The patient is asymptomatic, and there are no plans for revision surgery.The surgeon will continue to monitor the patient.
Additional Manufacturer Narrative
The implant remains in situ.Radiograph images were provided.The lot number was not provided; therefore, a review of the device history records could not be performed.Based on the information provided, the root cause could not be determined.Alphatec spine is submitting this report to comply with the fda regulations 21 cfr 803.Alphatec spine has made reasonable efforts to provide as much relevant information as available.Any field left blank was not known at the time of this submission.
Additional Manufacturer Narrative
Correction: radiograph images were not provided; therefore, the complaint cannot be confirmed.Additional information: h7: recall.H9: z-1065-2025.

• 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: 21235255
• Report Number: 2027467-2025-00012
• Device Sequence Number: 8056422
• Product Code: MAX
• UDI-Device Identifier: 00190376533018
• UDI-Public: (01)00190376533018
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K232504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: 325-07103015
• Device Catalogue Number: 325-07103015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 06/17/2025
• 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