BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMINOPLASTY FIXATION SYSTEM

    MDR report key: 5094001 · Received September 22, 2015

    Report

    Report Number
    2031966-2015-00053
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 22, 2015
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NQW
    PMA / PMN Number
    K091623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO RADIOGRAPHS WERE RECEIVED AND THE EVENT COULD NOT BE CONFIRMED. THE IMPLANTS WERE DISCARDED BY THE HOSPITAL, NO PRODUCT INFORMATION GIVEN AND NO FURTHER PRODUCT INVESTIGATION CAN BE COMPLETED AT THIS TIME. IT IS UNKNOWN IF THE PATIENT COMPLIED WITH POST-OPERATIVE CARE INSTRUCTIONS. THE PATIENT REPORTEDLY FELL PRIOR TO THE EVENT, BUT IT IS UNKNOWN IF THIS CONTRIBUTED TO THE EVENT. ROOT CAUSE HAS NOT BEEN DETERMINED, NO CONCLUSION CAN BE DRAWN. PRODUCT LABELING INDICATES: "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, FRACTURE OF THE VERTEBRA, AND VASCULAR OR VISCERAL INJURY. IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND OR BREAK. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PATIENT'S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT". IMPLANTS WERE DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    LAMINOPLASTY FIXATION SYSTEM WAS IMPLANTED ON (B)(6) 2015 IN A (B)(6) FEMALE AT C3. ON (B)(6) 2015 THE PATIENT SUSTAINED A FALL AND WAS REVISED ON (B)(6) 2015 FOR A LAMINA FRACTURE. PATIENT IS STABLE AND IS DOING WELL POST-REVISION. IMPLANTS WERE DISCARDED BY THE HOSPITAL. NO MALFUNCTION OF THE CONSTRUCT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626046 LAMINOPLASTY FIXATION SYSTEM ORTHOSIS, SPINE, PLATE. LAMINOPLSTY METAL NQW NUVASIVE, INC. 7650108

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization