BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSION PIP

    MDR report key: 1023718 · Received April 2, 2008

    Report

    Report Number
    1651501-2008-00005
    Event Type
    Other
    Date Received
    April 2, 2008
    Date of Event
    February 5, 2008
    Report Date
    March 7, 2008
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS WERE MADE TO RETRIEVE IMPLANTS FROM HOSPITAL PATHOLOGY DEPT, BUT DEVICES WERE NOT RETURNED TO ASCENSION ORTHOPEDICS. THEREFORE, EVALUATION WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    SURGEON REMOVED PROXIMAL AND DISTAL COMPONENTS DUE TO A FRACTURE OF THE PROXIMAL COMPONENT. IT IS NOT KNOWN WHETHER THE FRACTURE OCCURRED INTRA-OPERATIVELY OR POST-OPERATIVELY. IMPLANTS WERE SENT TO HOSP PATHOLOGY DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PIP TOTAL FINGER JOINT IMPLANT KWF ASCENSION ORTHOPEDICS, INC. PIP-200 07-1716

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other