BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY MITEK, INC.

    MDR report key: 4199252 · Received October 21, 2014

    Report

    Report Number
    MW5038788
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD DEPUY MITEK INTERFERENCE SCREW PLACED 10 MONTHS AGO TO RIGHT KNEE. SUBSEQUENTLY, RIGHT KNEE HAD SIGNIFICANT BULGING. DR. (B)(6) SCHEDULED PT FOR SURGERY. UPON INCISION, SCREW FOUND AND EASILY RETRIEVED WITH FORCEPS. CULTURES PERFORMED. (THIS SPECIFIC SCREW IS BIOABSORBABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670062 DEPUY MITEK, INC. INTERFERENCE SCREW HWC DEPUY MITEK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other