BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2473881 · Received February 21, 2012

    Report

    Report Number
    2520274-2012-00237
    Event Type
    Injury
    Date Received
    February 21, 2012
    Report Date
    January 26, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    DZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INFORMATION RECEIVED FROM THE FACILITY. INFORMATION NOT PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    A PT, IMPLANTED WITH THREE (3) MANDIBLE PLATES AND TWENTY-FIVE (25) SCREWS IN (B)(6) 2011 WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE DUE TO INFECTION. UPON REMOVAL IT WAS NOTED THAT ALL OF THE HARDWARE WAS INTACT. PT WAS REVISED TO 6 HOLES FROM A 20 HOLE MATRIXMANDIBLE PLATE, 5 2.4MM LOCKING SCREWS AND 1 2.4MM NON-LOCKING SCREW. PT HAD BEEN IMPLANTED AT ANOTHER FACILITY IN ANOTHER STATE BY A DIFFERENT SURGEON. THIS REPORT IS #24 OF 28 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS 24 OF 28 FOR COMPLAINT FILE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW SCREW DZL SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention