BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALLU-S PLATE SIZE 2 LEFT

    MDR report key: 836572 · Received April 4, 2007

    Report

    Report Number
    9615741-2007-00018
    Event Type
    Injury
    Date Received
    April 4, 2007
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION, AND AN EVALUATION OF THE PRODUT WILL BE CONDUCTED.

    Description of Event or Problem · 1

    PLATE BROKE. PRODUCT WAS IN CONTACT WITH THE PATIENT BUT NO INJURY WAS REPORTED. ACCORDING TO THE INTEGRA PRODUCT SPECIALIST, PRIOR TO IMPLANTING THE PLATE, THE DOCTOR BENT THE PLATE TO REDUCE THE DORSIFLEXION TO APPROXIMATELY 5 DEGREES. THE DOCTOR REPORTS THAT THIS PATIENT PRESENTED WITH COMPLAINT DURING POST OPERATIVE CARE. THE S PLATE BROKE AFTER SEVERAL WEEKS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALLU-S PLATE SIZE 2 LEFT HALLU-FIX SYSTEM PLATE HRS NEWDEAL S.A. * D386

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention