BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM TI CORTEX SCREW COARSE PITCH SELF-TAPPING 6MM

    MDR report key: 2993691 · Received March 7, 2013

    Report

    Report Number
    1719045-2013-00483
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K954385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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. IMPLANT DATE IS REPORTED AS APPROXIMATELY (B)(6) 2012.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT WAS TREATED FOR SELF-INFLICTED GUNSHOT WOUND BY AN UNKNOWN SURGEON AT AN UNKNOWN HOSPITAL IN (B)(6), ON AN UNKNOWN DAY IN APPROXIMATELY (B)(6) 2012. PATIENT HAS EXPERIENCED ON-GOING PAIN AND PRESENTED TO ORAL SURGEON ON AN UNKNOWN DATE. EXAMINATION REVEALED A NON-UNION. PATIENT WAS RETURNED TO O.R. ON (B)(6) 2013 FOR REVISION SURGERY. SURGEON REMOVED PREVIOUS HARDWARE, DEBRIDED THE AREA, REMOVED BONE, AND PLACED A 2.4MM LOCKING RECONSTRUCTION PLATE AND 2.4MM LOCKING SCREWS, ALONG WITH ARCHBARS. THIS IS 4 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97334 2.0MM TI CORTEX SCREW COARSE PITCH SELF-TAPPING 6MM JEY SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention