BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX SCREW Ø1.85 SELF-TAP L5 TAN 1U I/

    MDR report key: 3183593 · Received June 22, 2013

    Report

    Report Number
    2520274-2013-03403
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 3, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. THE ADDITIONAL EVALUATION REVEALED THAT THE SCREW HAS CLEARLY VISIBLE STRESS MARKS AND THAT THE THREAD FLANK IS PARTIALLY SHEARED OFF. THE MEASURABLE DIMENSIONS OF THE SCREW AND THE PLATES WERE AS FAR AS POSSIBLE CHECKED AND FOUND ACCORDING TO THE SPECIFICATION. OUR INVESTIGATION HAS SHOWN THAT SUCH AN OCCURRENCE CAN EITHER HAPPEN BY AN EXCESSIVE CONTACT WITH THE PLATE WHEN THE SCREW IS INSERTED IN AN EXTREME ANGLE OR WHEN THE PLATE WAS DAMAGED BY DRILLING PREVIOUSLY. IN THE ENCLOSED PICTURES IT IS VISIBLE THAT THE PLATE IS DAMAGED. IT IS IMPOSSIBLE TO DETERMINE IF THE DAMAGES WERE CAUSED BY AN EXCESSIVE SCREW CONTACT OR THE DRILL BIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORTHOGNATHIC SURGERY USING MATRIX ORTHOGNATHIC PLATE AND SCREW, THE SURGEON DISCOVERED A METAL THREAD WHEN INSERTING THE SCREW. THE SURGEON TURNED THE SCREW BACK AND THE THREAD APPEARED. IT WAS IN THE POSTERIOR PART OF THE LEFT SIDE OF THE MANDIBLE. THE HOLE IN THE SAGITTAL PLATE IS MARKED WITH AN ELASTIC BAND. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284315 MATRIX SCREW Ø1.85 SELF-TAP L5 TAN 1U I/ JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR