BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02784

    MDR report key: 3123617 · Received May 22, 2013

    Report

    Report Number
    2520274-2013-02784
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2013, THE PATIENT WAS TREATED FOR A DISTAL RADIUS FRACTURE. DURING THE PROCEDURE, A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) SCREW NEEDED TO BE REMOVED. DURING THE REMOVAL OF THE VA-LCP SCREW, THE HEAD OF THE LOCKING SCREW IN THE MOST DISTAL HOLE WAS FOUND TO BE BROKEN. AFTER THE EXTRACTION OF ALL OTHER SCREWS AND PLATES, THE RESIDUE OF THE SHAFT FROM THE BONE SURFACE WAS REMOVED BY THE EXTRACTION BOLT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225968 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1