BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.85MM SELF-TAPPING SCREW

    MDR report key: 2862670 · Received December 10, 2012

    Report

    Report Number
    2520274-2012-03704
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO CATALOG NUMBER OR LOT NUMBER WAS PROVIDED. NOTE: THIS DEVICE IS USED FOR TREATMENT. BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    PATIENT HAD A MATRIX ORTHOGNATHIC PROCEDURE DONE ON BOTH RIGHT AND LEFT SIDES OF THE MANDIBLE ON (B)(6) 2012. EACH SIDE CONSISTED OF ONE PLATE AND FOUR 1.85 MM SELF-TAPPING SCREWS. THE PATIENT WAS AN IN-PATIENT AND NEEDED A REVISION DONE ON THE LEFT SIDE OF THE MANDIBLE BECAUSE THE OCCLUSION WAS NOTED AS COMPLETELY OUT OF PLACE. PATIENT UNDERWENT A BILATERAL SAGITTAL SPLIT OSTEOTOMY REVISION TO REPLACE THE HARDWARE ON THE LEFT AND RIGHT SIDE OF THE MANDIBLE ON (B)(6) 2012. THE LEFT SIDE CAUSED THE RIGHT SIDE TO SHIFT AND SURGEON ALSO RESTORED THE OCCLUSION ON THE RIGHT SIDE OF THE MANDIBLE SURGEON WAS UNABLE TO REPOSITION THE RIGHT SIDE CONSTRUCT WITHOUT REMOVING AND REPLACING THE HARDWARE. THE SURGEON REMOVED THE 1 PLATE AND 4 SELF TAPPING SCREWS ON THE LEFT AND RIGHT SIDE AND REPLACED IT WITH ANOTHER PLATE AND SCREW CONSTRUCT (1 PLATE, 4 SCREWS). THE PLATE HOLES WERE TOO BIG TO HOLD THE ORIGINAL 4 SELF TAPPING SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INCIDENTS. EXPLANTED HARDWARE WAS DISCARDED BY THE HOSPITAL. THIS IS THE 2ND OF 10 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.85MM SELF-TAPPING SCREW JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE, SCREWS