BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASPAR DISTR PIN12MMSTET

    MDR report key: 8252254 · Received January 16, 2019

    Report

    Report Number
    8252254
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 10, 2018
    Report Date
    January 8, 2019
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS SURGEON WAS REMOVING THE 12MM DISTRACTION PIN, THE TIP BROKE OFF. PACKAGING WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44918 CASPAR DISTR PIN12MMSTET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH AESCULAP IMPLANT SYSTEMS, LLC FF912SB

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA