BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCP SZ. 40 PROXIMAL WW

    MDR report key: 3624310 · Received December 9, 2013

    Report

    Report Number
    1651501-2013-00045
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Date of Event
    November 11, 2013
    Report Date
    December 9, 2013
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    NEG
    PMA / PMN Number
    P000057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE PT INITIALLY RECEIVED "CONSERVATIVE TREATMENT" FOLLOWING AN ACCIDENT IN (B)(6). WHEN HE RETURNED TO (B)(6) WITH X-RAYS, THERE WAS LOSS SUBSTANCE IMPACTING THE GREATER PART OF THE METACARPAL HEAD. SURGERY WAS PERFORMED WHICH WAS NOTED AS "TENOARTHROLYSE DORSAL PROSTHETIC ARTHROPLASTY SECOND METACAPROPHALANGEAL (WITH ASCENSION IMPLANT)" MCP-100-40P-WW, LOT 11-1465. THE IMPLANT BROKE DURING INSTALLATION." ADDITIONAL INFO WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639729 MCP SZ. 40 PROXIMAL WW NEG ASCENSION ORTHOPEDICS 11-1465

    Patients

    Seq Age Sex Outcome Treatment
    1