BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL INTRAPHARANGEAL JOINT TRIAL

    MDR report key: 1942142 · Received November 15, 2010

    Report

    Report Number
    1651501-2010-00031
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    March 2, 2009
    Report Date
    November 15, 2010
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    MPK
    PMA / PMN Number
    H010005
    Removal / Correction Number
    Z-1524-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS KNOWN THAT THE TRIALS THAT WERE SENT BACK WERE OF AN OLDER DESIGN. ACTIONS WERE BEING TAKEN TO FURTHER INVESTIGATE THE EVENT. 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 SIZING DIFFERENCES (Z-1524-2010).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE TRIALS SEEMED TO BE LARGER THAN THE ACTUAL IMPLANT. THE METAL TRIALS WOULD NOT SEAT FLUSH DURING SURGERY EVEN AFTER BROACHES WERE COMPLETELY SEATED AND THE BONE WAS CUT CORRECTLY. THE DISTRIBUTED NOTED THAT THIS WAS NOT AN OBSERVATION FROM JUST ONE SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other