BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM X 24MM PRIMARY OPEN POLY SCREW

    MDR report key: 3886547 · Received April 11, 2014

    Report

    Report Number
    2184052-2014-00061
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Report Date
    March 13, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT HE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW BROKE POST-OPERATIVELY. THE PATIENT PRESENTED WITH PAINFUL HARDWARE. REVISION WAS PERFORMED TO REMOVE ALL HARDWARE. UPON EXPLORATION, THE RIGHT C2 SCREW WAS FOUND TO BE ALREADY BROKEN "IN SITU". THE BROKEN PIECE WAS REMOVED AND SCRAPPED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221532 3.5MM X 24MM PRIMARY OPEN POLY SCREW 3.5MM X 24MM PRIMARY OPEN POLY SCREW NKB ZIMMER SPINE, INC. 2112-3524 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR