BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBRACE GRAFT CONTAINMENT DEVICE

    MDR report key: 2911262 · Received December 14, 2012

    Report

    Report Number
    2031966-2012-00057
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K070148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REPORTEDLY THE FIRST USE OF THE EMBRACE SYSTEM BY THE SURGEON. NUVASIVE SURGICAL TECHNIQUE DOCUMENTATION SPECIFIES PROPER USE OF THE SIZING TEMPLATE. REVIEW OF NUSIL PRODUCT INFO WITH (B)(4). NO RADIOGRAPHS HAVE BEEN MADE AVAILABLE TO CONFIRM THE REPORTED EVENT; HOWEVER, SURGICAL TRAY INSPECTION NOTED THE TRIAL WAS NOT PRESENT IN THE TRAY FOLLOWING THE SURGERY. THE INTENDED IMPLANT WAS PRESENT IN THE TRAY. ROOT CAUSE OF THE EVENT IS BELIEVED TO BE RELATED TO USE ERROR.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT INADVERTENT IMPLANTATION OF A SILICONE SIZING INSTRUMENT OCCURRED IN LIEU OF THE INTENDED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBRACE GRAFT CONTAINMENT DEVICE APPLIANCE, FIXATION, SPINAL INTERVERT BODY KWQ NUVASIVE, INC. 7522450 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1