BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH

    MDR report key: 3892411 · Received June 24, 2014

    Report

    Report Number
    2530088-2014-00059
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. NO SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR FUSION PROCEDURE AT L5-S1, THE SURGEON ATTEMPTED TO INSERT THE LOCKING CAP INTO THE SCREW WITH THE BOTTOM LOADING CAP GUIDE AND THE LOCKING CAP BECAME CROSSED THREADED WITH THE SCREW. SURGEON CONFIRMED BOTH OF THE BOTTOM LOADING CAP BECAME BENT. SURGEON BACKED OUT THE LOCKING CAP AND SCREW AND USED A NEW SCREW. AFTER IMPLANTING THE SECOND ROD, THE SURGEON WAS REMOVING THE ROD INTRODUCER FROM THE ROD AND THE RELEASE MECHANISM BROKE INTO THE SURGEONS HAND. THE BROKEN FRAGMENT WAS RETRIEVED. SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. THE PATIENT WAS UNHARMED. PER ADDITIONAL INFORMATION RECEIVED, ON (B)(6) 2012 IT WAS REPORTED THE SURGEON WAS INSERTING THE ROD DOWN AND THE ROD INTRODUCER WOULD NOT BRAKE WHEN PULLING THE BRAKING TRIGGER. THE SURGEON WAS ABLE TO PERSUADE THE ROD INTO PLACE WITHOUT USING THE ROD INTRODUCER. THE SURGEON WAS MADE AWARE BY THE CONSULTANT THAT THE SPRING INSIDE THE ROD INTRODUCER APPEARED TO BE DAMAGED. SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. THE PATIENT WAS UNHARMED. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367911 7.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6669772

    Patients

    Seq Age Sex Outcome Treatment
    1 7.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LE