BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOMED

    MDR report key: 420960 · Received October 4, 2002

    Report

    Report Number
    MW1026369
    Event Type
    Malfunction
    Date Received
    October 4, 2002
    Date of Event
    September 12, 2002
    Report Date
    September 17, 2002
    Manufacturer
    OSTEOMED CORP.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING 5MM SCREWS INTO BONE FLAP THE TIP OF 2 SCREWS BROKE OFF INTO THE BONE. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOMED 5MM SCREWS HWC OSTEOMED CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR