MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INSIGNIA; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 436-0238

Device Problem Material Separation (1562)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

No device evaluation possible as it remains in the patient.Radiograph images were provided.There is a visible loose radiopaque piece anterior to the plate.It is unknown if the radiopaque piece is part of the locking mechanism.The identifying lot number was not provided; therefore, a review of the device history record could not be performed.The root cause is could not be determined.Labeling review: "warnings/cautions precautions: potential risks identified with the use of this device, which may require additional surgery, include device component fracture, loss of fixation, non-union, fracture of the vertebrae, and necrosis of bone, neurological injury and vascular or visceral injury." "possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation and or breakage of device components.".

Event Description

On (b)(6) 2024, a patient underwent a 2-level anterior cervical discectomy and fusion procedure.It was reported one of the locking mechanisms separated from the plate postoperatively.There are no plans for revision surgery.The patient is asymptomatic.

• Brand Name: INSIGNIA
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 18983076
• MDR Text Key: 338690627
• Report Number: 2027467-2024-00017
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00190376491073
• UDI-Public: (01)00190376491073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213443
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 436-0238
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Male