BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE LATERAL PLATE SYSTEM

    MDR report key: 2232973 · Received July 22, 2011

    Report

    Report Number
    2031966-2011-00033
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K091071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 EVAL; NO ROOT CAUSE HAS BEEN IDENTIFIED. SHOULD PRODUCT BECOME AVAILABLE, ANY RELEVANT INFO WILL BE INCLUDED IN A F/U 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 ADD'L 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

    AN XLP LATERAL PLATE ASSEMBLY WAS REPORTEDLY IMPLANTED ON OR ABOUT (B)(6) 2011. AT A F/U VISIT RADIOGRAPHS REVEALED ONE OF TWO LOCK NUTS HAD LOOSENED. SPINE LEVELS AND ADD'L DETAILS REGARDING THE CONSTRUCT HAVE NOT BEEN MADE AVAILABLE. IT WAS ALSO REPORTED THAT THE LOCK NUT WAS INSERTED UPSIDE DOWN. NO PT INJURY OCCURRED. SURGEON REPORTED THERE WERE NO PLANS FOR CONSTRUCT REVISION.

    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