BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP SZ. 20 PROXIMAL

    MDR report key: 2485606 · Received March 7, 2012

    Report

    Report Number
    1651501-2012-00022
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Date of Event
    February 23, 2012
    Report Date
    March 7, 2012
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KYJ
    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 NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A SURGICAL PROCEDURE, WHEN THE SURGEON TRIED TO IMPLANT IT, THE IMPLANT BROKE ON INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP SZ. 20 PROXIMAL KYJ ASCENSION ORTHOPEDICS 11-2981

    Patients

    Seq Age Sex Outcome Treatment
    1