BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPHERX PPS SYSTEM

    MDR report key: 1633460 · Received March 11, 2010

    Report

    Report Number
    2031966-2010-00004
    Event Type
    Other
    Date Received
    March 11, 2010
    Report Date
    March 10, 2010
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K082332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR FAILURE INVESTIGATION AND NO ADDITIONAL EVALUATION HAS BEEN POSSIBLE; HOWEVER, ANALYSIS OF SIMILAR DEVICES IS IN PROCESS. ATTEMPTS TO REPRODUCE THE FAILURE IN A LAB SETTING HAVE BEEN INCONCLUSIVE AND ROOT CAUSE IS UNK AT THIS TIME. PRODUCT LABELING INDICATES "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA AND VASCULAR OR VISCERAL INJURY." IDENTIFICATION OF THE ROOT CAUSE FOR THIS FAILURE MODE IS PENDING.

    Description of Event or Problem · 1

    DURING A POST-OPERATIVE OFFICE VISIT FOLLOWING A BILATERAL, 2-LEVEL TRANSFORMINAL INTERBODY FUSION AT L3-4 AND L4-5, RADIOGRAPHS SHOWED THAT A SCREW TULIP APPEARED TO HAVE SEPARATED FROM ITS SCREW SHANK. PT REPORTED NO SYMPTOMS AT THAT TIME. THE PT CONTINUES TO BE ASYMPTOMATIC AND NO ADDITIONAL INTERVENTION IS PLANNED. SURGEON RELATED THAT IT WAS POSSIBLE THE TULIP WAS NOT FULLY SEATED AT THE TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPHERX PPS SYSTEM SPINAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK