MAUDE Adverse Event Report: ALPHATEC SPINE, INC INSIGNIA¿ ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 236-1-24018

Device Problems Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problem Failure of Implant (1924)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

At the 3-month postoperative visit, a radiograph revealed a screw backout at c6.

Manufacturer Narrative

Radiographs were provided to confirm the event.The implant remains in the patient.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 performed.The root cause could not be determined at this time.If additional information is received, a supplemental report will be submitted.

• Brand Name: INSIGNIA¿ ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): 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: 15464996
• MDR Text Key: 306246583
• Report Number: 2027467-2022-00058
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00190376329796
• UDI-Public: 00190376329796
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 236-1-24018
• Device Catalogue Number: 236-1-24018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2022
• 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: 54 YR
• Patient Sex: Male