BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    MDR report key: 4062639 · Received September 5, 2014

    Report

    Report Number
    2520274-2014-13446
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    PK083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON WAS PLACING A MIDFACE SCREW INTO THE ZYGOMATIC ARCH. THE SCREW HEAD BROKE OFF. A HEMOSTAT WAS USED TO REMOVE THE THREADS LEFT IN THE BONE. THE SURGEON THEN REDRILLED THE HOLE MADE BY THE BROKEN SCREW AND INSERTED A NEW SCREW WITHOUT ANY ISSUES. THERE WAS A SECOND SCREW THAT BROKE ON THE LEFT FRONTAL BONE WHEN BEING PLACED. THE SCREW BODY WAS REMOVED WITH A HEMOSTAT AND DRILLED ON ANOTHER PLACE. ALL REMAINS OF THE SCREWS WERE REMOVED FROM THE PATIENT. THERE WAS A 5 MINUTE DELAY. THIS IS REPORT NUMBER 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545303 TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM BONE PLATE JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR