BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE

    MDR report key: 1082271 · Received July 25, 2008

    Report

    Report Number
    9681442-2008-00106
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    February 17, 2006
    Report Date
    January 16, 2007
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    KNW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNK. THE SAMPLE WAS NOT RETURNED, SO A SAMPLE EVAL COULD NOT BE PERFORMED. BASED ON THE INFO RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE USER FACILITY MEDWATCH REPORT THAT, "PT UNDERGOING BONE BIOPSY. BONE WAS DENSE, DUE TO CANCER. NEEDLE WAS BEING MANIPULATED BY HAND AND BROKE OFF. SURGEON WAS CONSULTED FOR REMOVAL OF NEEDLE." NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE KNW ANGIOMED GMBH & CO. MEDIZINTE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other