BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES LOCKING TARSAL PLATE

    MDR report key: 4377650 · Received December 24, 2014

    Report

    Report Number
    MW5039851
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    November 24, 2014
    Report Date
    December 24, 2014
    Manufacturer
    SYNTHES, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING REMOVAL OF HARDWARE PLACED IN HIS FOOT FRACTURE IN (B)(6) 2013. ONE OF THE SCREWS IN THE HARDWARE WAS FOUND TO BE BROKEN AND THE TIP COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849875 SYNTHES LOCKING TARSAL PLATE LOCKING TARSAL PLATE SET HRS SYNTHES, INC. 2. 4/2.7 MM LOCKING TARSAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other