BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM TI CURVED ROD 65MM

    MDR report key: 3952750 · Received July 23, 2014

    Report

    Report Number
    2520274-2014-12753
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES; MNH, MNI, KWQ, KWP. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE ROD WAS RETURNED WITH THE ANODIZED FINISH WORN IN MULTIPLE AREAS. ON THE END OF THE ROD, A LARGE AREA OF WEAR IS VISIBLE AND IS LIKELY EVIDENCE OF THE RUBBING CAUSED BY THE LOOSE LOCKING CAP. ONE 6.0MM TITANIUM MATRIX POLYAXIAL SCREW, ONE TITANIUM MATRIX LOCKING CAP, ONE 5.5MM TITANIUM CURVED ROD WERE RETURNED FOR THE LOCKING CAP REPORTEDLY BEING LOOSE. THE MATRIX SPINE SYSTEM IS A THORACOLUMBAR PEDICLE SCREW SYSTEM DESIGNED TO PROVIDE FLEXIBILITY, BIOMECHANICAL PERFORMANCE AND A TOTAL SOLUTION TO COMPLEX POSTERIOR PATHOLOGICAL CHALLENGES PER TECHNIQUE GUIDES. PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. THE THREADS OF THE LOCKING CAP AND POLYAXIAL HEAD ARE DESIGNED WITH A 10 DEGREE MODIFIED SQUARE THREAD. THE MODIFIED SQUARE THREAD DESIGN MINIMIZES CROSS-THREADING UNDER HIGH REDUCTION LOADS AND OFF-AXIS TECHNIQUES, AND THE THREAD ANGLE MINIMIZES FRICTION BETWEEN THE THREADS. THIS REDUCED FRICTION ALLOWS FINAL TIGHTENING OF THE LOCKING CAP AND COMPRESSION OF THE CONSTRUCT TO OCCUR WITH A 10NM TORQUE TO PREVENT BREAKING OF THE DRIVERS, ALTHOUGH IT ALSO EASES LOOSENING. IMPROPER TECHNIQUE CONTRIBUTED TO THE CAP LOOSENING AS THE TECHNIQUE GUIDE INCLUDES WARNINGS AND CAUTIONS STATING THAT IF THE COUNTER TORQUE IS NOT USED DURING FINAL TIGHTENING, CONSTRUCT LOOSENING MAY OCCUR AND FINAL TIGHTENING OF THE LOCKING CAP SHOULD ONLY BE PERFORMED WITH A CALIBRATED, SYNTHES 10NM TORQUE HANDLE. MATRIX SCREW IMPLANTS ACHIEVE PERFORMANCE STANDARD ONLY WHEN TIGHTENED TO THE REQUIRED 10NM TIGHTENING TORQUE. THERE ARE MULTIPLE SITUATIONS THAT MAY HAVE LED TO THE COMPLAINT CONDITION. THE LOCKING CAP IS DESIGNED WITH MODIFIED SQUARE THREADS. WHILE THESE THREADS HAVE LOWER FRICTION COMPARED TO STANDARD 60 DEGREE V-THREADS, THERE ARE MULTIPLE TECHNIQUE ERRORS THAT ALSO CONTRIBUTED TO THE CAP LOOSENING. THE EXACT ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY FOR NON-UNION. THE ORIGINAL PROCEDURE AT AN UNKNOWN DATE HAD BEEN FOR A FUSION OF L4-S1 SPINE AND THE MATRIX SYSTEM WAS IMPLANTED. DURING THE REVISION, THE SURGEON WAS REMOVING A POSTERIOR LUMBAR SCREW (04.632.645), AND NOTICED THAT THE LEFT LUMBAR S1 SCREW CAP WAS LOOSE. THE LOOSE CAP WAS RUBBING ON THE ROD (04.636.065); THE CAP FROM THE SCREW HEAD WAS ALSO SUSPECTED TO BE AT THE LOCATION OF THE NON-UNION. THE SCREW WAS REPLACED WITH A LARGER DIAMETER SCREW, BUT THE SAME LENGTH (04.632.745), AND A NEW ROD OF THE SAME LENGTH WAS REPLACED ON BOTH SIDES OF THE CONSTRUCT AND COCR CAPS (09.632.099). ALL SIX SCREWS/CAPS OF THE CONSTRUCT WERE REPLACED PER THE SURGEON'S DISCRETION. THIS REPORT IS 3 OF 6 FOR COMPLAINT COM-(B)(4).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED; THE SALES CONSULTANT WHO CONFIRMED THE ORIGINAL CONSTRUCT WAS PLACED AT L4-S1, THE LOOSE SCREW CAP WAS AT LUMBAR S1 AND THE NON-UNION OCCURRED AT L5-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431405 5.5MM TI CURVED ROD 65MM ORTHROSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES MEZZOVICO 3787453

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention