BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL

    MDR report key: 3003371 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-10204
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. BLANK FIELDS ON THIS FORM INDICATE THE INFO IS UNK, UNAVAILABLE OR UNCHANGED. DEVICES(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD¿L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE SAMPLE WAS RETURNED ASSEMBLED WITH THE SCREW ENGAGED INTO THE BODY/COLLET. MFG VISUAL EVAL NOTED THE MARKS ON THE STARDRIVE NOT CONSISTENT WITH MFG. DUE TO THE PART RETURNED IN THE ASSEMBLED CONDITION, ALL FEATURES PERTINENT TO THE REPORTED CONDITION COULD NOT BE MEASURED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN L4-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE THE SURGEON REMOVED THE INTERBODY DISTRACTOR, AND THE PREASSEMBLED HEAD OF THE SCREW POPPED OFF INTRAOPERATIVELY. THE PIECE WAS RETRIEVED, AND THE SURGEON SELECTED ANOTHER SCREW AND COMPLETED THE PROCEDURE WITH NO FURTHER COMPLICATION. THERE WAS NO EFFECT TO THE PATIENT AND THE TIME OF THE PROCEDURE WAS NOT SIGNIFICANTLY EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86592 7.0MM TI MATRIX POLYAXIAL NKB SYNTHES (USA) 6565743

    Patients

    Seq Age Sex Outcome Treatment
    1