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

Model Number 320-08103000

Device Problem Collapse (1099)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

The implant remains in the patient.It was used for treatment, not diagnosis.The original surgery date is unknown.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Neither photographs nor radiographs were provided to confirm the event.Based on the information provided, a root cause could not be determined.If additional information, a supplemental report will be filed accordingly.

Event Description

It was reported around one year postoperative, the lordotic expandable cage had collapsed.The patient is asymptomatic.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: 16773220
• MDR Text Key: 313632715
• Report Number: 2027467-2023-00030
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00190376396798
• UDI-Public: (01)00190376396798
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 320-08103000
• Device Catalogue Number: 320-08103000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2023
• 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