BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING DEVICE 13.5MM/15MM

    MDR report key: 2948156 · Received April 27, 2007

    Report

    Report Number
    2530088-2007-00033
    Event Type
    Malfunction
    Date Received
    April 27, 2007
    Date of Event
    March 30, 2007
    Report Date
    March 30, 2007
    Manufacturer
    SYNTHES (USA)
    Product Code
    HXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. DEVICE HAS BEEN REC'D AND INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A VERY SMALL PIECE OF THE TIP OF THE AIMING DEVICE BROKE OFF IN AN IMPLANT INTRAOPERATIVELY AND SURGEON ELECTED NOT TO ATTEMPT RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIMING DEVICE 13.5MM/15MM AIMING DEVICE HXO SYNTHES (USA) NA 5407677

    Patients

    Seq Age Sex Outcome Treatment
    1