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

Model Number	325-09103010
Medical Device Problem Codes	Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown whether the patient was admitted to the hospital.The cage remains in the patient, and the cause of their pain is unknown.The identifying lot number was not provided and could not be confirmed.If additional information is provided, a supplemental report will be filed accordingly.
Event or Problem Description
On (b)(6) 2024, the patient had a spinal procedure in which an expandable interbody cage was placed at the l3-l4.Approximately 2.5 months post-surgery, the patient presented to the hospital with pain and concerns about a possible collapse of the cage.Imaging results were inconclusive.No revision surgery is planned at this time, and the surgeon will continue to monitor the patient's condition.
Additional Manufacturer Narrative
Additional information: b5.The pain the patient experienced was unrelated to the device failure.It was during this visit that x-rays were performed, which showed a possible collapse of the implant.Corrected information: h6.Health effect - impact code: remove 4648, add 2199.Medical device component code: remove 2993, add 3189.
Additional Manufacturer Narrative
H7.Recall.H9.Z-1065-2025.

• Brand Name: CALIBRATE
• 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: 20363992
• Report Number: 2027467-2024-00117
• Device Sequence Number: 17066215
• Product Code: MAX
• UDI-Device Identifier: 00190376533377
• UDI-Public: (01)00190376533377
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 325-09103010
• Device Catalogue Number: 325-09103010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/20/2024; 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male