BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSION PIP IMPLANT

    MDR report key: 1626422 · Received February 11, 2010

    Report

    Report Number
    1651501-2010-00003
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    November 25, 2009
    Report Date
    February 11, 2010
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    NEG
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS WERE REVIEWED AND NOTHING WAS IDENTIFIED TO INDICATE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. IT HAS BEEN REQUESTED THAT THE PRODUCT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT A PT WOULD BE REVISED DUE TO A BROKEN PROXIMAL IMPLANT. SURGERY WAS SCHEDULED TO OCCUR ON (B)(6) 2010 BUT WAS POSTPONED DUE TO A BLOOD BLISTER. THE LOCATION AND DETAILS OF THE BLISTER IS STILL BEING INVESTIGATED. IT IS UNK IF THE DEVICE CAUSED OR CONTRIBUTED TO THE BLOOD BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PIP IMPLANT FINGER PYROLYTIC CARBON PROSTHESIS NEG ASCENSION ORTHOPEDICS, INC. PIP-200-40P 06-1353

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R