BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE LATERAL PLATE SYSTEM

    MDR report key: 2211996 · Received July 8, 2011

    Report

    Report Number
    2031966-2011-00031
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Report Date
    July 5, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K091071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNCLEAR IF THE VERTEBRAL FRACTURE CONTRIBUTED TO THE LOOSENED CONSTRUCT. REVISION SURGERY HAS NOT OCCURRED. ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A SUBSEQUENT REPORT WILL BE FILED. 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

    AN XLIF PROCEDURE INCORPORATING A LATERAL PLATE ASSEMBLY WAS PERFORMED ON (B)(6) 2011. DURING A FOLLOW-UP VISIT, THE PATIENT REPORTED BACK PAIN AT THE SURGERY SITE. RADIOGRAPHS WERE TAKEN, REVEALING A POTENTIAL VERTEBRAL BODY FRACTURE AND SUPERIOR SCREW LOCK NUT SEPARATION ON THE XLP PLATE. NO REVISION SURGERY IS 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1