BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION SILICON PIP

    MDR report key: 2230674 · Received August 12, 2011

    Report

    Report Number
    1651501-2011-00064
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYJ
    PMA / PMN Number
    K082231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER EVALUATION. THE DEVICE IS CURRENTLY UNDER EVALUATION AND THE INVESTIGATION INTO THE EVENT IS ONGOING. LITTLE INFORMATION ABOUT THE EVENT HAS BEEN PROVIDED AT THIS POINT. WHEN THE DEVICE EVALUATION IS COMPLETED AND IF ANY ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORTED WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SILICONE PIP COMPONENT FRACTURED AT THE HINGE. THE DEVICE WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION SILICON PIP FINGER POLYMER CONSTRAINED PROSTHESIS KYJ ASCENSION ORTHOPEDICS, INC. SPIP-520-01

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R