BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALIGN

    MDR report key: 8705999 · Received June 17, 2019

    Report

    Report Number
    1421101-2019-00001
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    March 22, 2019
    Report Date
    June 14, 2019
    Manufacturer
    AVALIGN GERMAN SPECIALTY INSTRUMENTS
    Product Code
    HAE
    UDI-DI
    00190776000547
    PMA / PMN Number
    K081651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS MANUFACTURED DECEMBER 2006, SOLD TO REPORTING FACILITY NETWORK UNDER 2 INVOICES: JANUARY 2007 AND MARCH 2007. PER K081651, DEVICES ARE PROVIDED NON-STERILE AND REUSABLE. THE DEVICES ARE SHOWN TO WITHSTAND A MINIMUM OF 20 CYCLES WHEN STERILIZED ACCORDING TO THE INSTRUCTIONS.

    Description of Event or Problem · 1

    FRONT PORTION OF DEVICE BROKE OFF INTO PATIENT'S BRAIN TISSUE WHILE IN USE. THE BROKEN PORTION OF THE INSTRUMENT WAS RETRIEVED AND THE INSTRUMENT WAS REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497506 AVALIGN MICRO KERRISON, 40 DEGREE UP, 9MM OPENING, TW 2 MM, SL 203 MM(8"), OL 270MM(10") HAE AVALIGN GERMAN SPECIALTY INSTRUMENTS 120406 00190776000547

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention