MAUDE Adverse Event Report: SPINAL ELEMENTS, INC AMENDIA CERVICAL PLATE SYSTEM; ANTERIOR CERVICAL PLATE

Model Number 12-35-4514

Device Problem Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Date 12/03/2021

Event Type  Injury  

Event Description

Reportedly the flange of the cam (the locking mechanism on an acp plate) fractured.Subsequentially it was reported that the bone screw backed out, with no harm to the patient.Revision surgery was preformed to replace the screw.

Manufacturer Narrative

No images of the alleged 'screw backout' were provided to confirm the event.Returned plate and screws were evaluated and one of the flange on the locking cam on the acp plate fractured off and was returned in the 'open position.' it is unknown if the cam was in the open position at the time of the original surgery.Of the screws returned, it is unknown which one allegedly backed out.There was no damage to the bone screws that would suggest a mechanical failure.Unknown factors include: patient activity at the time or prior to the event, duration to failure, patient bone quality, the degree of spinal instability, patient compliance with postoperative care instructions, or if the patient sustained a fall/impact of any sort.Root cause of the bone screw loosening is unknown.

• Brand Name: AMENDIA CERVICAL PLATE SYSTEM
• Type of Device: ANTERIOR CERVICAL PLATE
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 13061173
• MDR Text Key: 282627265
• Report Number: 3004893332-2021-00026
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00840916127749
• UDI-Public: 00840916127749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12-35-4514
• Device Catalogue Number: 12-35-4514
• Device Lot Number: 144737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2018
• 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 Outcome(s): Required Intervention