BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM

    MDR report key: 7904303 · Received September 24, 2018

    Report

    Report Number
    2939274-2018-53932
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    August 24, 2018
    Report Date
    August 31, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZL
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: JEY. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    IT WAS REPORTED PATIENT UNDERWENT A CRANIOTOMY WITH INSERTION OF ELECTRODE ARRAY ON (B)(6) 2018. WHILE THE SURGEON AS INSERTING ONE (1) 6MM AND TWO (2) 8MM MATRIXMIDFACE SCREWS INTO THE HOUSING FOR THE ARRAY, THE SCREW HEAD CAME OFF. THE REMAINING PORTION OF THE SCREW REMAINS EMBEDDED IN PATIENT¿S BONE. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN UNSPECIFIED DELAY. CONCOMITANT DEVICE REPORTED: NON-SYNTHES ELECTRODE ARRAY (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 6MM MATRIXMIDFACE SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743386 TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM SCREW FIXATION INTRAOSSEOUS DZL WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR