BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE LATERAL PLATE SYSTEM

    MDR report key: 2152827 · Received June 27, 2011

    Report

    Report Number
    2031966-2011-00028
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K091071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT ASSEMBLY MAY HAVE CAUSED THE REPORTED EVENT. NO REVISION SURGERY HAS OCCURRED AND NO PRODUCT HAS BEEN AVAILABLE FOR EVALUATION; NO ROOT CAUSE HAS BEEN IDENTIFIED. SHOULD PRODUCT BECOME AVAILABLE, ANY RELEVANT INFO WILL BE INCLUDED IN A FOLLOW-UP REPORT. PUBLISHED SURGICAL TECHNIQUE DEPICTS THE APPROPRIATE ORIENTATION OF THE LOCK NUT WITHIN THE INSTRUMENT PRIOR TO INSERTION. INSTRUCTIONS FOR USE NOTE THE FOLLOWING: "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, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY."

    Description of Event or Problem · 1

    FOLLOWING AN XLIF CASE WITH IMPLANTATION OF A LATERAL PLATE ASSEMBLY, IT WAS REPORTED THAT THE PLATE'S LOCK NUTS AND LOOSENED; ONE NUT WAS ENTIRELY LOOSENED AND ONE NUT WAS PARTIALLY LOOSENED. THE LOCK NUTS WERE REPORTEDLY INSTALLED UPSIDE DOWN. PT INFO, SURGERY DATES, AND EVENT DATE ARE UNKNOWN AT THIS TIME. RADIOGRAPHS HAVE NOT BEEN PROVIDED FOR REVIEW. THE PT IS REPORTEDLY ASYMPTOMATIC AND REVISION SURGERY IS REPORTEDLY NOT PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE LATERAL PLATE SYSTEM SPINAL INTERVERT BODY FIXATION ORTHOSIS KWQ NUVASIVE, INC. 7510001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1