BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUVASIVE COROENT SYSTEM

    MDR report key: 1730149 · Received June 16, 2010

    Report

    Report Number
    2031966-2010-00014
    Event Type
    Other
    Date Received
    June 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K071795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS NOT BEEN RETURNED TO NUVASIVE AND PHYSICAL EVALUATION OF THE EXPLANTED DEVICE HAS NOT BEEN POSSIBLE. LABELING REVIEW INCLUDES THE FOLLOWING: "THE SYSTEM IS INTENDED TO BE USED WITH SUPPLEMENTAL INTERNAL SPINE FIXATION SYSTEMS CLEARED FOR USE IN THE LUMBAR SPINE. INTERNAL FIXATION DEVICES ARE LOAD-SHARING DEVICES THAT HOLD BONY STRUCTURES IN ALIGNMENT UNTIL HEALING OCCURS. IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND OR BREAK." IN THE EVENT THAT ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUBSEQUENT REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A PATIENT WITH L4-L5 DEGENERATIVE DISC DISEASE RECEIVED A PARTIAL DISCECTOMY WITH PLACEMENT OF A NUVASIVE COROENT XL IMPLANT. DURING FOLLOW-UP OFFICE VISIT, RADIOGRAPHS NOTED THE IMPLANT HAD MIGRATED 1CM OUT OF THE DISC SPACE. THE SURGEON REPORTED THAT THE MOST PROBABLE REASON FOR THE MIGRATION WAS THE AMOUNT OF RESIDUAL TENSION FROM THE PARTIAL DISCECTOMY, THUS RESULTING IN A LACK OF ENGAGEMENT BETWEEN THE IMPLANT AND THE VERTEBRAL ENDPLATES. REVISION SURGERY INCLUDED A COMPLETE ANNULAR RELEASE AND A LARGER INTERBODY IMPLANT PLACEMENT IN THE DISC SPACE. THERE WAS NO REPORTED ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE COROENT SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX NUVASIVE, INC. 6981255 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other