BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPHERX PPS SYSTEM

    MDR report key: 1647071 · Received March 25, 2010

    Report

    Report Number
    2031966-2010-00005
    Event Type
    Other
    Date Received
    March 25, 2010
    Date of Event
    February 11, 2010
    Report Date
    March 25, 2010
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K082332
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT MEETS BOTH DIMENSIONAL AND PERFORMANCE CHARACTERISTICS. THE INVESTIGATION INTO ROOT CAUSE REMAINS IN PROCESS. 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."

    Description of Event or Problem · 1

    INITIAL SURGERY OCCURRED ON (B)(6) 2010. PATIENT DIAGNOSIS UNKNOWN. PROCEDURE TYPE NOTED TO BE OPEN TRANSFORAMINAL INTERBODY FUSION AT L4-L5. POST-SURGERY (DATE UNKNOWN) THE PATIENT REPORTEDLY FELT A "POP"; RADIOGRAPH NOTED A SEPARATION OF THE TULIP FROM THE SCREW SHANK AT L5. REVISION SURGERY WAS PERFORMED ON (B)(6) 2010. THE SCREW WAS REPLACED AT THAT TIME WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPHERX PPS SYSTEM SPINAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC. 7782002 JK4026

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other