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

Model Number 320-07102500

Device Problem Collapse (1099)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

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 records could not be conducted.Based on the information provided, a root cause could not be determined.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.

Event Description

At the 3-month postoperative visit, radiographic images revealed a collapsed expandable cage.The patient is asymptomatic and is being monitored.There are no plans for revision surgery.

• 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: 18497927
• MDR Text Key: 333118340
• Report Number: 2027467-2023-00094
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190376321585
• UDI-Public: (01)00190376321585
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 320-07102500
• Device Catalogue Number: 320-07102500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Male