BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL INTRAPHARANGEAL JOINT TRIAL

    MDR report key: 1628027 · Received March 8, 2010

    Report

    Report Number
    1651501-2010-00010
    Event Type
    Injury
    Date Received
    March 8, 2010
    Date of Event
    May 20, 2008
    Report Date
    March 8, 2010
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    NEG
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DESIGN WAS COMPLETED. IT WAS DETERMINED THAT THE CURRENT VERSION OF TRIALS WERE SLIGHTLY LARGER THAN THE IMPLANT. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND LITTLE INFORMATION WAS PROVIDED ABOUT THE TRIALS INVOLVED WITH THIS EVENT, IT COULD NOT BE VERIFIED THAT IT WAS THE SAME DESIGN. IT WAS ALSO UNCLEAR IF THE SLIGHTLY LARGER SIZE HAD CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PROXIMAL INTRAPHARANGEAL TRIAL JOINT WAS BEING PLACED INTO THE PATIENT, THE BONE HAD FRACTURED. A SUTURE WAS USED TO CORRECT THE EVENT.

    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 Required Intervention