BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIP SZ. 30 PROXIMAL

    MDR report key: 2800942 · Received October 18, 2012

    Report

    Report Number
    1651501-2012-00050
    Event Type
    Injury
    Date Received
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    MPK
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER NOTED: "THE PROXIMAL PART OF THE PIP IMPLANT BROKE (LESS THAN ONE YEAR AFTER THE IMPLANTATION)". ADDITIONAL INFORMATION WAS RECEIVED. THE EVENT WAS NOTED AS "STEM RUPTURE OF THE PROXIMAL PART OF PIP PYROCARBON". THIS WAS NOTICED ON (B)(6) 2012. THERE WERE NO SIGNS OF INFECTION. THE INITIAL SURGERY WAS PERFORMED ON THE PT'S RIGHT "LONG" FINGER ON (B)(6) 2011; ' "REINTERVENTION" WAS ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP SZ. 30 PROXIMAL PIP MPK ASCENSION ORTHOPEDICS 10-2272

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR