BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 3925208 · Received July 10, 2014

    Report

    Report Number
    2520274-2014-12492
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    PK042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE BROKE DURING INSERTION; DEVICE WAS NOT IMPLANTED/EXPLANTED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING CLOSING THE SKULL WITH THE MATRIXNEURO STERILE KIT ONE SCREW HEAD BROKE OFF THE SCREW DURING SCREWING IN THE SKULL. THIS SCREW WITHOUT SCREW HEAD STAYED IN PATIENT¿S SKULL AND NEW SCREWS FROM THE SET WERE USED. THE SECOND SCREW HEAD IS LITTLE DAMAGED, SOME PARTICLES CAME OFF. THE CONDITION OF THE PATIENT IS STABLE. THERE WAS NO DELAY IN SURGERY. NO SPECIAL ACTION IS TAKEN. SCREWS STAYED IN THE PATIENT AND NEW SCREWS WERE USED TO CLOSE THE SKULL. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404538 TI MATRIXNEURO SCREW SELF-DRILLING 4MM BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1