BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø1.5 SELF-TAP L6

    MDR report key: 3171642 · Received June 15, 2013

    Report

    Report Number
    2520274-2013-03254
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    March 5, 2012
    Report Date
    March 5, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    K981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE SCREW WAS RECEIVED AND EVALUATED, AND CONFIRMED TO BE SHEARED HALFWAY DOWN THE SHAFT. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHICH INDICATE MATERIAL CONFORMITY. THE MEASURABLE DIMENSIONS, OF THE COMPLAINED SCREWS COULD NOT BE CHECKED FOR ITS SPECIFICATION AS THERE WERE NO LOT NUMBERS PROVIDED. THE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS EVENT OCCURRED DURING A PROCEDURE ON (B)(6) 2012. TWO SYNTHES 1.5MM X 6MM SCREWS WERE IMPLANTED INTO THE TEMPORAL BONE TO SECURE DOWN LIGAMENTAL ATTACHMENTS. THE 1.1MM DRILL BIT WAS USED TO DRILL THE HOLE FOR THE SCREW. THEN THE SCREW WAS INSERTED. DURING INSERTION THE SCREW HAS SHEARED HALFWAY DOWN THE SHAFT. THE TIP WAS LEFT IN PLACE. THE HEAD AND REMAINING SHAFT WERE RETRIEVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272631 CORTSCR Ø1.5 SELF-TAP L6 MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1