BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX SCREW Ø1.85 SELF-TAP L6 TAN 4U I/

    MDR report key: 3024116 · Received March 27, 2013

    Report

    Report Number
    2520274-2013-01632
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 19, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: DURING AN OSTEOTOMY ON (B)(6) 2013 A MATRIX SCREW CONSTRUCT WAS IMPLANTED. REPORTEDLY 20 MINUTES AFTER THE SCREWS WERE IMPLANTED THE SURGEON DISCOVERED THE PATIENT WAS BLEEDING AND HAD TO REMOVE THE SCREWS AND THE PLATE. THERE WAS DIFFICULTY REMOVING THE SCREWS AND THE HEADS SHEARED OFF MANY OF THE SCREWS. THE SURGEON CUT THROUGH THE PLATE TO REMOVE THE CONSTRUCT. A PORTION OF A SCREW WAS LEFT IN THE PATIENT TO PREVENT ANY HARM DURING REMOVAL. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125671 MATRIX SCREW Ø1.85 SELF-TAP L6 TAN 4U I/ JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1