BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDIAL LISFRANC PLATE - UNKNOWN

    MDR report key: 1943833 · Received December 21, 2010

    Report

    Report Number
    9615741-2010-00070
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 21, 2010
    Manufacturer
    NEWDEAL
    Product Code
    HRS
    Adverse Event
    Yes
    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 EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PT HAD A SURGICAL PROCEDURE USING THE ADVANSYS MID FOOT PLATING SYS: MEDIAL LISFRANC PLATE (PRODUCT CATALOGUE NUMBER NOT PROVIDED TO DATE). TWO WEEKS POST OPERATIVELY, THE PT HAD A TENDON RUPTURE. REMOVAL OF THE PLATE IS PLANNED IN (B)(6) 2011. THE PT WILL REQUIRE A TENDON PLASTY. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIAL LISFRANC PLATE - UNKNOWN ADVANSYS HRS NEWDEAL

    Patients

    Seq Age Sex Outcome Treatment
    1