BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIP SZ. 20 PROXIMAL

    MDR report key: 2484819 · Received March 6, 2012

    Report

    Report Number
    1651501-2012-00023
    Event Type
    Other
    Date Received
    March 6, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 6, 2012
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A SURGICAL PROCEDURE, THE IMPLANT WAS PLACED INTO HARD BONE OF THE PROXIMAL PHALANX, HOWEVER, THE SURGEON ELECTED TO REMOVE IT AS IT WAS NOT FITTING PROPERLY. UPON REMOVAL IT WAS SHATTERED, LEAVING 3/4 OF THE IMPLANT IN THE PATIENT. THE RETAINED PART OF THE IMPLANT WAS REMOVED AND THE SURGERY WAS CONTINUED. THE PROCEDURE WAS PROLONGED BY ABOUT ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP SZ. 20 PROXIMAL PIP KYJ ASCENSION ORTHOPEDICS, INC. 11-2738

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention