BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT RESECTION ABLATOR, 4.2MM

    MDR report key: 640844 · Received August 25, 2005

    Report

    Report Number
    1017294-2005-00160
    Event Type
    Malfunction
    Date Received
    August 25, 2005
    Report Date
    July 27, 2005
    Manufacturer
    LINVATEC CORPORATION
    Product Code
    HXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SHOULDER ACROMIAL DECOMPRESSION PROCEDURE THE TIP OF THE DEVICE BROKE OFF. THE TIP WAS RETRIEVED WITHIN A COUPLE OF MINUTES. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT RESECTION ABLATOR, 4.2MM RESECTION ABLATOR HXR LINVATEC CORPORATION NA BBB89764

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR