BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03519

    MDR report key: 3173571 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03519
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICES IMPLANTED APPROXIMATELY FIVE MONTHS PRIOR TO AWARENESS DATE. DEVICES EXPLANTED (B)(6) 2013. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO MATRIX MIDFACE L PLATES AND 14 SCREWS HAD TO BE REMOVED FROM THE PATIENT DUE TO LACK OF SOFT TISSUE COVERAGE. THIS IS REPORT 1 OF 2 FOR COMPLAINT 43743 AND REFERS TO TWO MATRIX MIDFACE L PLATES OF UNKNOWN PART NUMBER AND UNKNOWN LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273673 MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention