BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-05265

    MDR report key: 3324184 · Received September 4, 2013

    Report

    Report Number
    2520274-2013-05265
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Report Date
    August 7, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THIS REPORT IS FOR 2 UNKNOWN RODS. ADDITIONAL PRODUCTS: NKB, MNH KWP KWQ. INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    IN REVIEWING TWO SURGEON PRESENTATIONS IT WAS NOTED THAT WHAT APPEAR TO BE SYNTHES MATRIX RODS HAVE BROKEN BILATERALLY. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438502 MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR