BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION PIP

    MDR report key: 1970277 · Received January 14, 2011

    Report

    Report Number
    1651501-2011-00004
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    June 14, 2006
    Report Date
    January 14, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    NEG
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VERY LITTLE INFORMATION WAS SUPPLIED ABOUT THIS EVENT AND ATTEMPTS ARE BEING TAKEN TO OBTAIN ANY ADDITIONAL INFORMATION. IF ANY ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENT REPORT WILL BE SUBMITTED IF APPROPRIATE.

    Description of Event or Problem · 1

    DURING THE INITIAL SURGERY, THE SURGEON ENCOUNTERED VERY SCLEROTIC BONE, WITH NARROWING OF THE INTRA-MEDULLARY CANALS OF THE PHALANGES. THIS REQUIRED THAT THE SURGEON USE A BURR TO WIDEN THE INTRA-MEDULLARY CANALS ENABLING THE SURGEON TO RASP FOR THE COMPONENTS. BECAUSE OF THE BURRING, THERE WAS A STRESS RISER IN THE MIDDLE PHALANX. DURING THE FIRST POST-OPERATIVE VISIT, X-RAYS REVEALED A TRANSVERSE FRACTURE OF THE MIDDLE PHALANX JUST DISTAL TO THE IMPLANT. THE FRACTURE WAS TREATED WITH A FINGER SPLINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PIP FINGER PYROLYTIC CARBON PROSTHESIS NEG ASCENSION ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R