BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERX PPS SYSTEM

    MDR report key: 3881720 · Received May 21, 2014

    Report

    Report Number
    2031966-2014-00033
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 21, 2014
    Manufacturer
    NUVASIVE INC.
    Product Code
    NKB
    PMA / PMN Number
    K090981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE SCREW REMAINS IN THE PT AND HAS NOT BEEN RETURNED, AND NO FURTHER EVAL OF THE PRODUCT CAN BE COMPLETED AT THIS TIME. THESE DEVICES ARE NOT DESIGNED TO WITHSTAND THE UNSUPPORTED STRESS OF THE FULL WEIGHT OR LOAD BEARING ALONE. THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOAD ASSOCIATED WITH DELAYED UNION OR NON-UNION AND WILL DICTATE THE LONGEVITY OF THE IMPLANT. IT IS UNK IF THE PT SUSTAINED SOME IMPACT OR FALLEN. THE ROOT CAUSE OF THIS REPORTED EVENT HAS NOT BEEN DETERMINED; NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE REPORT INDICATES THAT FOUR MONTHS POST OPERATIVELY, THE PT REPORTED THAT SHE HAD BACK PAIN, BUT STILL APPEARS TO BE DOING WELL. UPON REVIEW ON (B)(6), IT WAS DISCOVERED THAT THE LEFT 5MM PEDICLE BONE SCREW SHANK AT S1 FRACTURED. SURGEON WILL CONTINUE TO MONITOR AND THERE IS NO PLAN FOR REVISION SURGERY AT THIS TIME. THE INITIAL PLIF (POST LATERAL INTERBODY FUSION SURGERY) WAS PERFORMED ON (B)(6) 2013 TO FUSE L5-S1 VERTEBRAL BODIES. DURING THE (B)(6) F/U, THE PT AND THE CONSTRUCT WERE FINE. PT'S ACTIVITY LEVEL IS UNK. PT COMPLIANCE WITH POST-SURGICAL INSTRUCTIONS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301667 SPHERX PPS SYSTEM BONE-SCREW INTERNAL SPINAL FIXATION SYST NKB NUVASIVE INC. 7075035

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR