BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIX 1.85MM LOCKING SCREWSELF-TAPPING/5MM

    MDR report key: 3539245 · Received December 27, 2013

    Report

    Report Number
    1719045-2013-02116
    Event Type
    Malfunction
    Date Received
    December 27, 2013
    Date of Event
    November 28, 2013
    Report Date
    November 28, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN IMPLANT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF DEVICE HISTORY RECORDS REVIEW REVEALED NO ISSUES RELATED TO THE COMPLAINT FOR THIS PRODUCT LOT. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(4) 2013; THAT DURING THE SURGERY ON (B)(6) 2013 EIGHT MATRIX SCREWS OF MOJ (MATRIX ORTHOGNATHIC JAPAN) FOR THE SAGITTAL SPLIT RAMUS OSTEOTOMY OPERATION WERE USED. ONE OF THE SCREWS COULD NOT PICK UP WITH EITHER THE STRAIGHT DRIVER OR THE CONTRA ANGLE TORQUE DRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678513 TI MATRIX 1.85MM LOCKING SCREWSELF-TAPPING/5MM JEY SYNTHES MONUMENT 7416059

    Patients

    Seq Age Sex Outcome Treatment
    1