BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECKER RONGEUR CUP 2 X 6MM 6IN

    MDR report key: 5245391 · Received November 6, 2015

    Report

    Report Number
    8010282-2015-00004
    Event Type
    Malfunction
    Date Received
    November 6, 2015
    Date of Event
    September 10, 2015
    Report Date
    October 26, 2015
    Manufacturer
    WEBA MEDIZINTECHNIK GMBH & CO.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THERE WERE NO FAILURES IN THE HARDENING PROCESS DETECTED DURING MANUFACTURING. THEREFORE FAILED HARDENING CAN BE EXCLUDED. DEVICE WAS NOT USED AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA EMAIL, THAT THE TIP BROKE OFF INSIDE THE PATIENT AND THEY HAD TO FISH IT OUT. ON (B)(6) 2015, ADDITIONAL INFORMATION WAS OBTAINED. THE TIP BROKE OFF DURING A LUMBER ONE LEVEL PROCEDURE. A C-ARM X-RAY WAS USED TO VERIFY. THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739632 DECKER RONGEUR CUP 2 X 6MM 6IN NA HTX WEBA MEDIZINTECHNIK GMBH & CO. NL6250 XWAV02

    Patients

    Seq Age Sex Outcome Treatment
    1 NI