BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02858

    MDR report key: 3131958 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02858
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE APPROXIMATELY 1.5 YEARS BEFORE THE EVENT. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    CONSULTANT REPORTED A HARDWARE REMOVAL TOOK PLACE ON (B)(6) 2013. PATIENT WAS IMPLANTED APPROXIMATELY 1-1/2 YEARS AGO, PRESENTED TO SURGEON COMPLAINING OF PAIN. EXAM ON UNKNOWN DATE REVEALED 3 OF THE 3.5MM LOCKING SCREWS IN THE PROXIMAL END OF THE LOCKING COMPRESSION PLATE (LCP) MEDIAL DISTAL TIBIA PLATE WERE BROKEN. PATIENT WAS RETURNED TO OR ON (B)(6) 2013, TO REMOVE HARDWARE- THE PLATE WHICH WAS UNBROKEN AND INTACT, AND THE SCREWS - 3 OF WHICH WERE BROKEN. IT IS NOT KNOWN IF ANY SCREW SHAFT FRAGMENTS REMAIN IMPLANTED. PATIENT WAS REVISED TO SUBTALAR FUSION USING HEADLESS COMPRESSION SCREWS. THERE WAS NO EXTENSION OF SURGERY TIME DUE TO BROKEN SCREWS. PATIENT IS REPORTEDLY RECOVERING WELL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237602 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention