BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 5MM

    MDR report key: 3073383 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10818
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    June 14, 2012
    Report Date
    June 15, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. (B)(6). 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.

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2012. NEW INFORMATION WAS RECEIVED (B)(6) 2013.

    Description of Event or Problem · 1

    SURGEON REPORTED TO CONSULTANT THAT DURING A CRANIOTOMY FOR TUMOR, A FEW SCREW HEADS BROKE OFF. ALL PIECES WERE RETRIEVED WITH NO FURTHER HARM TO PATIENT. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175536 TI MATRIXNEURO SCREW SELF-DRILLING 5MM JEY SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR