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

Model Number 320-08102500

Device Problem Collapse (1099)

Patient Problem Pain (1994)

Event Date 06/26/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 320235253
• Report Number: 2027467-2023-00042
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190376396781
• UDI-Public: (01)00190376396781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1