BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON

    MDR report key: 5825343 · Received July 27, 2016

    Report

    Report Number
    5825343
    Event Type
    Malfunction
    Date Received
    July 27, 2016
    Date of Event
    July 11, 2016
    Report Date
    July 25, 2016
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    HAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF A KERRISON BROKE OFF IN PATIENT DURING USE. THE SURGEON WAS ABLE TO REMOVE THE TIP WITH THE USE OF THE MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478096 KERRISON PUNCH, SURGICAL HAD AESCULAP IMPLANT SYSTEMS, LLC 7 IN 1MM

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR