BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL INTRAPHARANGEAL JOINT TRIAL

    MDR report key: 1942141 · Received November 15, 2010

    Report

    Report Number
    1651501-2010-00029
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    July 8, 2008
    Report Date
    November 15, 2010
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    NEG
    PMA / PMN Number
    H010005
    Removal / Correction Number
    Z-1524-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE TRIALS WAS COMPLETED. IT WAS CONFIRMED THAT THE TRIALS THAT WERE SENT BACK WAS OF AN OLDER DESIGN. IT WAS KNOWN THAT THESE TRIALS WERE OF AN OLDER DESIGN THAT HAD SIZING DIFFERENCES BETWEEN THEM AND THE ACTUAL IMPLANT. A RECALL WAS INITIATED TO ADDRESS THIS EVENT (Z-1524-2010).

    Description of Event or Problem · 1

    SURGEON REPORTED THAT HE HAD A FEELING THAT THE PROXIMAL INTRAPHARANGEAL (PIP) METAL TRIALS WERE NOT CORRECT IN IT'S DIMENSIONS. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMAL INTRAPHARANGEAL JOINT TRIAL FINGER SEMI-CONSTRAINED PROSTHESIS TRIAL NEG ASCENSION ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other