BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINGER PYROLYTIC CARBON PROSTHESIS

    MDR report key: 1870084 · Received October 1, 2010

    Report

    Report Number
    1651501-2010-00023
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYJ
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. MANUFACTURING RECORDS WERE REVIEWED. NOTHING WAS IDENTIFIED IN THOSE RECORDS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. IF ANY ADDITIONAL INFO IS OBTAINED IN THIS EVENT, IT WILL BE REPORTED APPROPRIATELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIP PROXIMAL COMPONENT WAS ROTATING AND THAT REVISION SURGERY WAS PERFORMED. A LARGER SIZE COMPONENT WAS USED IN THE REVISION AND THE PT IS NOW REPORTED TO BE DOING FINE. NO REPORTED ISSUES WERE WITH THE DISTAL COMPONENT, BUT IT WAS REMOVED AND REPLACED DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINGER PYROLYTIC CARBON PROSTHESIS ASCENSION PIP - DISTAL KYJ ASCENSION ORTHOPEDICS, INC. PIP-200-10-D 09-1513

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R