BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 558110 · Received August 27, 2004

    Report

    Report Number
    MW1033109
    Event Type
    Malfunction
    Date Received
    August 27, 2004
    Date of Event
    August 9, 2004
    Report Date
    August 27, 2004
    Manufacturer
    BIOMET INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: VHS HIP: DURING SCREW INSERATION, BEFORE TIGHTENING SCREW, SCREW BROKE OFF. THE REMAINDER OF THE SCREW WAS LEFT IN THE BODY. PT TAKEN TO RECOVERY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET GEHRIG SCREWHEAD HWC BIOMET INC. VHS HIP SCREW *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR