BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP SZ 20 PROXIMAL

    MDR report key: 2781849 · Received October 5, 2012

    Report

    Report Number
    1651501-2012-00048
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYJ
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER NOTED ¿THERE WAS A SURGERY WITH THE RESULT OF A BROKEN PIP IMPLANT TODAY¿ NO FURTHER INFO WAS PROVIDED. ADD¿L INFO WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP SZ 20 PROXIMAL PIP KYJ ASCENSION ORTHOPEDICS, INC. 11-3407

    Patients

    Seq Age Sex Outcome Treatment
    1