BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES POLYAXIAL TITANIUM PEDICLE BONE SCREW

    MDR report key: 3032575 · Received March 28, 2013

    Report

    Report Number
    MW5029564
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SYNTHES
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MECHANICAL FAILURE OF POLYAXIAL TITANIUM PEDICLE BONE SCREWS. PT WAS REQUIRED TO UNDERGO ADDITIONAL SURGICAL PROCEDURE TO REPLACE THE BROKEN HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127402 SYNTHES POLYAXIAL TITANIUM PEDICLE BONE SCREW PEDICLE SCREW NKB SYNTHES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R