BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERX PPS SYSTEM

    MDR report key: 1882427 · Received October 20, 2010

    Report

    Report Number
    2031966-2010-00022
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 19, 2010
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K082332
    Product Problem
    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. THE FAILURE MODE HAS BEEN REPLICATED IN A LABORATORY SETTING, HOWEVER, ROOT CAUSE IS UNKNOWN AT THIS TIME. IDENTIFICATION OF THE ROOT CAUSE(S) FOR THIS FAILURE MODE ARE PENDING; ASSEMBLY TECHNIQUE IS BELIEVED TO PLAY A ROLE IN THE PROBABILITY OF OCCURRENCE. 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." A FOLLOW-UP REPORT WILL BE FILED WHEN NEW INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    APPROXIMATELY 11 WEEKS FOLLOWING SURGERY, THE SURGEON REPORTED THAT A PORTION OF THE SCREW ASSEMBLY HAD SEPARATED. THERE WERE NO NOTED BONE QUALITY ISSUES NOR ANY REPORTED ISSUES IN PATIENT COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS. REVISION SURGERY TO CORRECT IS NOT PLANNED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK