BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP, BROACH, PROXIMAL, SZ 20

    MDR report key: 3111776 · Received May 7, 2013

    Report

    Report Number
    1651501-2013-00008
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE DEVICE BROKE. BOTH PIECES HAVE BEEN RETRIEVED FROM THE PT. SEVERAL ATTEMPTS FOR ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197780 PIP, BROACH, PROXIMAL, SZ 20 PIP INSTRUMENTS LXH ASCENSION ORTHOPEDICS 7425-04

    Patients

    Seq Age Sex Outcome Treatment
    1