BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-04676

    MDR report key: 3247416 · Received July 25, 2013

    Report

    Report Number
    2520274-2013-04676
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN SPINAL IMPLANT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AFTER THE STERILIZATION, A HOSPITAL EMPLOYEE FOUND PIECES OF FLESH ON THE IMPLANT TRAY. AFTER THE CLEANING, THE SALES REPRESENTATIVE REQUESTED THE RE-STERILIZATION. THIS REPORT IS FOR AN UNKNOWN SPINAL IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349320 MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1