BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY MITEK SCREWS & WASHERS

    MDR report key: 531559 · Received June 28, 2004

    Report

    Report Number
    1221934-2004-00087
    Event Type
    Injury
    Date Received
    June 28, 2004
    Report Date
    June 25, 2004
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AN EMAIL WAS RECEIVED FROM THE FACILITY STATING A PT HAD RETURNED IN 2003 WITH AN INFECTION. ITEMS USED IN THE PROCEDURE WERE A SPIKE ROUND WASHER (221020) 20MM OD AND A (2204.30) 4.5 MMX 30MM CORTICAL SCREW PLACED IN THE DISTAL ASPECT OF THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY MITEK SCREWS & WASHERS SPIKED WASHER HWC DEPUY MITEK * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN