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

Model Number	320-08102500
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At the 2-week postoperative visit, a radiograph image revealed a unilateral collapse of an expandable cage.There are no plans for revision surgery.The surgeon will continue to monitor the patient.
Additional Manufacturer Narrative
The implant remains in-situ.A radiograph image was provided which confirmed the event.There are no plans for revision surgery.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided, a root cause could not be determined.If additional information is received, a supplemental report will be filed accordingly.

• 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: 17390556
• Report Number: 2027467-2023-00042
• Device Sequence Number: 20546573
• Product Code: MAX
• UDI-Device Identifier: 00190376396781
• UDI-Public: (01)00190376396781
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K211873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2023

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: 320-08102500
• Device Catalogue Number: 320-08102500
• Device Lot Number: UNKNOWN
• 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: 06/26/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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