BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIX ACP SYSTEM

    MDR report key: 2251327 · Received August 12, 2011

    Report

    Report Number
    2031966-2011-00038
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    May 24, 2011
    Report Date
    August 11, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K073275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED PRODUCT WAS REPORTEDLY NOT RETAINED AND IS UNAVAILABLE FOR EVAL. THE REASON FOR THE SCREW BACKOUT AND SUBSEQUENT REVISION WAS ATTRIBUTED BY THE SURGEON TO MOVEMENT OF THE SCREW WITHIN THE VERTEBRAL BODY. NO ADD'L EVAL CAN BE MADE AT THIS TIME. SHOULD ADD'L RELEVANT INFO BE OBTAINED, A F/U REPORT WILL BE FILED. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM WHICH MAY REQUIRE ADD'L SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S)."

    Description of Event or Problem · 1

    FOLLOWING PLACEMENT OF ANTERIOR CERVICAL PLATE AT THE C3-C7 SPINE LEVELS ON (B)(6) 2011, THE LEFT INFERIOR SCREW WAS NOTED TO HAVE LOOSENED. THE ISSUE WAS NOTED ON (B)(6) 2011 AND RE-EVALUATED ON (B)(6) 2011. REVISION SURGERY WAS PERFORMED ON (B)(6) 2011 AND INCLUDED REMOVAL/REPLACEMENT OF THE LOOSENED SCREW AS WELL AS THE ADJACENT (RIGHT INFERIOR) SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIX ACP SYSTEM SPINAL INT VERT BODY FIXATION ORTHOSIS KWQ NUVASIVE, INC. 7732113 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1