BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIAL LISFRANC PLATE - SMALL RIGHT

    MDR report key: 2484632 · Received March 7, 2012

    Report

    Report Number
    9615741-2012-00013
    Event Type
    Injury
    Date Received
    March 7, 2012
    Date of Event
    February 22, 2012
    Report Date
    March 7, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE 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 DAMAGE TO THE TIBIALIS ANTERIOR MUSCLE, THAT WAS RELATED TO THE DEVICE THAT HAD BEEN IMPLANTED ABOUT ONE YEAR AGO. A SURGICAL PROCEDURE WAS DONE TO REPAIR SOFT TISSUE. THE SURGEON OBSERVED NO ANOMALY OF THE PLATE, THE SCREWS OR THE POSITION OF THE IMPLANTED DEVICES DURING THE PROCEDURE. THE IMPLANTED DEVICES WERE NOT REMOVED. INTEGRA HAS REQUESTED MORE CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIAL LISFRANC PLATE - SMALL RIGHT NA HRS NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention