BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    MDR report key: 3082672 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10936
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 1, 2011
    Report Date
    November 1, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PART IS BROKEN AT THE NECK JUST BELOW THE HEAD. ONLY THE HEAD OF THE SCREW WAS RETURNED FOR EVALUATION. NO THREADS REMAIN ON THE RETURNED PART. SINCE ALL THE FEATURES RELEVANT TO THIS COMPLAINT COULD NOT BE CHECKED AND A REVIEW OF THE DHR COULD NOT BE COMPLETED THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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.INITIAL REPORT INDICATED A DHR COULD NOT BE COMPLETED. DHR IS REFERENCE TO THE DEVICE HISTORY RECORD (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TUMOR REMOVAL BEHIND THE RIGHT ORBIT, SURGEON TRIED TO INSERT THREE MATRIX MIDFACE SCREWS AND THEY CRUMBLED AND BROKE APART AS THE SURGEON WAS TRYING TO INSERT. SURGEON TRIED A FOURTH SCREW AND THE HEAD SNAPPED OFF LEAVING THE SHAFT OF THE SCREW IN THE PATIENTS BONE. SURGEON DID REMOVE THE SHAFT OF THE SCREW. SURGEON USED COMPETITORS SCREWS TO FINISH PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 4 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183858 TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR