BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM TI CORTEX SCREW SLF-DRLGW/PLUSDRIVE REC

    MDR report key: 2771933 · Received September 28, 2012

    Report

    Report Number
    1719045-2012-01004
    Event Type
    Injury
    Date Received
    September 28, 2012
    Report Date
    August 31, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZL
    PMA / PMN Number
    K963546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PATIENT WAS IMPLANTED WITH LEFORT 1 OSTEOTOMY (FOUR PLATES WITH 18 SCREWS) ON (B)(6) 2012. SIX WEEKS POST-OP, PATIENT DEVELOPED LEFT MAXILLARY SINUSITIS AND INCREASE IN PROMINENT IRRITATION NEAR THE LEFT ANTERIOR PLATE. CT REVEALED EDEMA AND MODERATE SEPTAL DEVIATION, AIR FLUID LEVEL MEMBRANE WAS THICK. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF ONE OF THE PLATES AND FIVE OF THE SCREWS. THE REMAINING THREE PLATES AND THIRTEEN SCREWS REMAIN IMPLANTED. THIS IS 5 OF 6 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0MM TI CORTEX SCREW SLF-DRLGW/PLUSDRIVE REC CORTEX SCREW SLF-DRLGW DZL SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention SCREW| PLATE