BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIODRIVE

    MDR report key: 1671716 · Received May 3, 2010

    Report

    Report Number
    2242816-2010-00063
    Event Type
    Malfunction
    Date Received
    May 3, 2010
    Date of Event
    January 18, 2010
    Report Date
    April 20, 2010
    Manufacturer
    BIOMET UK LTD
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PART INVOLVED IN EVENTPART NO. LOT NO. MFG DATE. 3242-050-048S 041-1584189 04/02/2009DHR WAS REVIEWED AND NO ANOMAILES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SCREWS WERE DISCOVERED BROKEN AFTER TALAR/NAVICULAR FUSION. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODRIVE 5.0X44MM OSSETITE SCREW HWC BIOMET UK LTD 04-1584186

    Patients

    Seq Age Sex Outcome Treatment
    1