BEUDAMED
    FDA Adverse Event Other Summary report: N

    HELIX ACP SYSTEM

    MDR report key: 3125296 · Received May 10, 2013

    Report

    Report Number
    2031966-2013-00026
    Event Type
    Other
    Date Received
    May 10, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K083341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RADIOGRAPHS CONFIRMED THAT ONE SUPERIOR SCREW BACK OUT. REVISION SURGERY OCCURRED ON (B)(6) 2013 IN WHICH THE SCREW WAS REMOVED AND ANOTHER SCREW WAS PLACED. EXPLANTED SCREW WAS RETURNED TO NUVASIVE FOR EVAL. SCREW MET DESIGN REQUIREMENTS AND PERFORMED TO SPECIFICATIONS. INFO SUGGESTS THAT UNION HAD NOT OCCURRED AT THE TIME OF THE BACK OUT. BASED ON THE DURATION TO EVENT ALSO SUGGESTS THAT THERE MIGHT BE A FAILURE OF THE BONE SCREW TO OSSEOINTEGRATE, RESULTING IN THE SCREW BACK OUT. PT ACTIVITY AT THE TIME OF THE EVENT IS UNK, BUT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE ROOT CAUSE OF THE FAILURE REMAINS UNK. REVIEW OF LABELING NOTES: WARNINGS, CAUTIONS AND PRECAUTIONS, "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYS, 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." "...LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PT'S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT."

    Description of Event or Problem · 1

    INITIAL SURGERY OCCURRED ON APPROX (B)(6) 2013 INVOLVING A TWO LEVEL ACDF AT C4-C6. ON (B)(6) 2013, PT UNDERWENT REVISION SURGERY TO REMOVE ONE SUPERIOR SCREW WAS REMOVED AND WAS REPLACED WITH A RESCUE SCREW. THE OTHER FIVE SCREW REMAINED INTACT. PT DID NOT SUSTAIN A FALL OR TRAUMA RELATED TO SCREW BACK OUT. PT ACTIVITY LEVEL DURING THE TWO AND A HALF MONTHS IS ALSO UNK. IT IS UNK IF THE PT WAS OTHERWISE COMPLIANT WITH POST OPERATIVE CARE. PT WAS REPORTEDLY ASYMPTOMATIC DURING THIS TIME AND FOLLOWING REVISION SURGERY, PT IS CURRENTLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209477 HELIX ACP SYSTEM SPINAL INT VERT BODY FIXATION ORTHOSIS KWQ NUVASIVE, INC. 7739115 DR2322

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention