BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM X 16MM PRIMARY OPEN POLY SREW

    MDR report key: 3971143 · Received July 8, 2014

    Report

    Report Number
    2184052-2014-00107
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 13, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE 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

    SAME CASE AS: 2184052-2014-00108. IT WAS REPORTED THE SCREWS BROKE POST-OPERATIVELY. LEVELS TREATED WERE OCC-C2 APPROXIMATELY 3 YEARS AGO. THE PATIENT WAS EXPERIENCING PAINFUL HARDWARE. AS WELL BOTH SCREWS AT C2 WERE FOUND TO BE BROKEN. REVISION SURGERY WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398407 3.5MM X 16MM PRIMARY OPEN POLY SREW 3.5MM X 16MM PRIMARY OPEN POLY SCREW NKB ZIMMER SPINE, INC. 2112-3516 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention