BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SULZER SPINE-TECH BONE HARVESTER

    MDR report key: 315426 · Received February 5, 2001

    Report

    Report Number
    2184052-2001-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2001
    Date of Event
    December 19, 2000
    Report Date
    February 2, 2001
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TIP OF BONE HARVESTER BROKE OFF IN PATIENT'S ILIAC CREST AND COULD NOT BE REMOVED. THE PT IS BEING MONITORED, HOWEVER THERE ARE CURRENTLY NO PLANS TO REOPERATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4304 SULZER SPINE-TECH BONE HARVESTER BONE HARVESTER HWE SULZER SPINE-TECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other