BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE

    MDR report key: 2802511 · Received October 24, 2012

    Report

    Report Number
    2520274-2012-02509
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 15, 2012
    Report Date
    September 25, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A RIGHT DISTAL TIBIA FRACTURE WITH EXTENSION INTO THE DIAPHYSIS PROCEDURE, THE SCREW BROKE DURING INSERTION IN THE PLATE. THE BROKEN FRAGMENT REMAINS IN THE PATIENT. THE BROKEN SCREW HEAD WAS RETRIEVED AND RETURNED FOR EVALUATION. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW