BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX LOCKING CAP

    MDR report key: 3072583 · Received April 23, 2013

    Report

    Report Number
    2530088-2013-10441
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    August 26, 2011
    Report Date
    August 26, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL PRODUCT CODE(S) FOR THIS REPORT INCLUDE, MNH, MNI, KWQ, KWP. MANUFACTURING EVALUATION REPORTS THAT THE PART WAS RECEIVED ASSEMBLED AND LOCKED TO THE POLYAXIAL SCREW ASSEMBLY. THE MARKS LOCATED ON THE BOTH THE STARDRIVE AND THREADS ARE NOT CONSISTENT WITH MANUFACTURING. DUE TO THE LOCKING CAP BEING STUCK IN THE POLYAXIAL SCREW ASSEMBLY, THE FEATURES RELATED TO THE COMPLAINT CONDITION, INCLUDING THE MATERIAL VERIFICATION, COULD NOT BE EVALUATED. THE DHR SHOWS THAT THE CORRECT MATERIAL WAS UTILIZED AT THE TIME OF MANUFACTURE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRODUCT DEVELOPMENT EVALUATION REVEALS, THE PART SHOWED TYPICAL SIGNS OF HAVING BEEN ASSEMBLED TO A CONSTRUCT AND THEN REMOVED. NO UNUSUAL DAMAGE OR IRREGULARITIES WERE LOCATED. THE DESIGN OF THE SYSTEM COMPONENTS ASSOCIATED WITH THIS COMPLAINT IS APPROPRIATE FOR THE CLINICAL INDICATIONS. THE TECHNIQUE GUIDE DISCUSSES THE PROPER STEPS AND INSTRUMENTATION REQUIRED FOR REMOVING A LOCKING CAP. THIS COMPLAINT IS DEEMED INVALID.

    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)(4) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A L5-S1 LUMBAR FUSION PROCEDURE, THE FINAL X-RAYS WERE TAKEN AFTER IMPLANTING HARDWARE ON (B)(6) 2011. X-RAYS SHOWED THAT THE ANGLE OF THE 6.0MM MATRIX SCREW AT L5 NEEDED READJUSTING. THE SURGEON REMOVED THE MATRIX LOCKING CAP FROM S1 WHILE THE 7.0MM MATRIX SCREW AND MATRIX TOP LOADING POLYAXIAL HEAD AT S1 REMAINED INTACT. THE SURGEON ATTEMPTED SEVERAL DIFFERENT TECHNIQUES TO REMOVE THE MATRIX LOCKING CAP, MATRIX TOP LOADING POLYAXIAL HEAD AND MATRIX SCREW AT L5. USING DIFFERENT TECHNIQUES IN AN ATTEMPT TO REMOVE THE LOCKING CAP AT L5, THE FOLLOWING INSTRUMENTATION BECAME DAMAGED, THE 10NM TORQUE LIMITING RATCHET TO REMOVE THE LOCKING CAPS, THE 1ST LOCKING CAP AT S1 WAS REMOVED. WHILE TRYING TO REMOVE THE 2ND LOCKING CAP AT L5, THE DEVICE WOULD NOT TURN AND THE LOCKING CAP COULD NOT BE REMOVED. THE RATCHET T-HANDLE STRIPPED WHEN PUT IN NEUTRAL. THE TEETH ON BOTH T25 STARDRIVE SHAFTS BENT AND THE TEETH ON THE SPORT GRIP T25 STARDRIVE BENT. SURGEON WAS NOT ABLE TO REMOVE THE LOCKING CAP AT L5 AND DECIDED TO CUT THE 5.5MM CURVED ROD IN HALF AND BACK OUT THE L5 SCREW AND POLYAXIAL HEAD WITH A PAIR OF VICE GRIPS. A NEW SCREW, LOCKING CAP AND POLYAXIAL HEAD WAS PLACED AT L5 AND PROCEDURE WAS COMPLETED. APPROXIMATELY 30-45 MINUTES WAS ADDED TO PROCEDURE. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174859 TI MATRIX LOCKING CAP NKB SYNTHES BRANDYWINE 6683230

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention