BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON DETACH 130DG UP 200MM 1MM THIN

    MDR report key: 3829813 · Received May 6, 2014

    Report

    Report Number
    2916714-2014-00340
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 6, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GXJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: EVAL ON-GOING.

    Description of Event or Problem · 1

    DECOMPRESSION SURGERY: TIP BROKE DURING SPINAL SURGERY IN THIN BONE. NO PT INJURY OR PROLONGING OF SURGERY REPORTED. FOOTPLATE IS COMPLETELY BROKEN FROM THE DEVICE. FOOTPLATE WAS DISCARDED. PIECE WAS ABLE TO BE EASILY REMOVED. MOMENTARY DELAY. NO ADD'L X-RAY WAS TAKEN IN ORDER TO LOCATE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270202 KERRISON DETACH 130DG UP 200MM 1MM THIN BONE PUNCH GXJ AESCULAP AG & CO. KG FK961B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other