BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM IMF SCREW SELF-DRILLING 12MM

    MDR report key: 3034054 · Received April 3, 2013

    Report

    Report Number
    1719045-2013-10471
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 2, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    DZL
    PMA / PMN Number
    K010527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. SCREW SHAFT REMAINS IMPLANTED. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMF PROCEDURE, THE SURGEON BEGAN INSERTING THE SCREWS ON THE BOTTOM RIGHT MANDIBLE AND 2 OF THE SCREW HEADS POPPED OFF UPON TIGHTENING. THE SCREW REMOVAL SYSTEM COULD NOT RETRIEVE THE 2 SCREW SHAFTS. THE SURGEON MADE THE DECISION TO LEAVE THE 2 SHAFTS IMPLANTED. SURGEON THEN COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137492 2.0MM IMF SCREW SELF-DRILLING 12MM DZL SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1