BEUDAMED
    FDA Adverse Event Summary report: N

    HTR-PMI

    MDR report key: 1770228 · Received July 21, 2010

    Report

    Report Number
    1770228
    Date Received
    July 21, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 21, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOMET SYNTHETIC IMPLANT (FIRST CHOICE FOR IMPLANT) FOR HEAD HAD POSSIBLE HAIR OR FUZZ ON THE IMPLANT WHILE STILL IN THE STERILE PACKAGING. THE 1ST CHOICE IMPLANT WAS GIVEN TO THE COMPANY REPRESENTATIVE AND THE 2ND CHOICE IMPLANT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTR-PMI PLATING SYSTEM HRS BIOMET MICROFIXATION PM610091 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR