BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH

    MDR report key: 3070227 · Received April 22, 2013

    Report

    Report Number
    2520274-2013-11125
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. 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. 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

    DURING A PROCEDURE, THE HEAD CAME OFF OF A MATRIX SCREW (PART NUMBER 04.632.750). THE SURGEON USED A DIFFERENT SCREW TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171325 7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1