BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECONSTRUCTIVE WEDGE P1 18X15X7

    MDR report key: 3241412 · Received July 22, 2013

    Report

    Report Number
    0001825034-2013-02816
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PK122770
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. LOT NUMBER & EXPIRATION DATE - UNKNOWN. - MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN EVAN'S WEDGE PROCEDURE ON (B)(6) 2013. WHEN PREPARING THE IMPLANT IT WAS NOTICED THERE WERE BURRS ON ONE EDGE. THESE WERE EASILY BRUSHED OFF AND THE IMPLANT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340859 RECONSTRUCTIVE WEDGE P1 18X15X7 PLATE, FIXATION, BONE HRS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention