BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTYCUT DISPOSABLE BONE BIOPSY NEEDLES

    MDR report key: 1850111 · Received September 21, 2010

    Report

    Report Number
    9681442-2010-00093
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    DWO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A BONE BIOPSY PROCEDURE, THE NEEDLE TIP BROKE OFF WHILE INSIDE THE PATIENT DURING REMOVAL. THE TIP WAS REMOVED SUCCESSFULLY. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTYCUT DISPOSABLE BONE BIOPSY NEEDLES DWO ANGIOMED GMBH & CO. MEDIZINTECHNIK

    Patients

    Seq Age Sex Outcome Treatment
    1