BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE COROENT INTERLOCK

    MDR report key: 2904385 · Received November 30, 2012

    Report

    Report Number
    2031966-2012-00054
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    September 6, 2012
    Report Date
    November 30, 2012
    Manufacturer
    NUVASIVE, INC.
    Product Code
    ODP
    PMA / PMN Number
    K102547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SURGEON INDICATED THE ALREADY-IMPLANTED COROENT SCREW MADE CONTACT WITH THE SUBSEQUENTLY-IMPLANTED SCREW AND MAY HAVE BEEN THE PROXIMATE CAUSE OF BREAKAGE. REVIEW OF FILMS PROVIDED TRENDS TO CORROBORATE THE PROXIMATE CAUSE. PHYSICAL INSPECTION OF THE SCREW REVEALED NO INDICATORS SUGGESTING A MFG DEFECT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES NO ANOMALOUS MANUFACTURING CONDITIONS. LABELING REVIEW: "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, 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." "BASED ON FATIGUE TESTING RESULTS, WHEN USING THE COROENT SMALL INTERLOCK SYSTEM, THE PHYSICIAN SHOULD CONSIDER THE LEVELS OF IMPLANTATION, PT WEIGHT, PT ACTIVITY LEVEL, OTHER PT CONDITIONS, ETC, WHICH MAY IMPACT ON THE PERFORMANCE OF THIS SYSTEM. CARE SHOULD BE TAKEN TO INSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE." "NOTCHING, STRIKING, AND/OR SCRATCHING OF IMPLANTS WITH ANY INSTRUMENT SHOULD BE AVOIDED TO REDUCE THE RISK OF BREAKAGE."

    Description of Event or Problem · 1

    A COROENT INTERLOCK WAS IMPLANTED IN A PT ON (B)(6) 2012. FOLLOWING THIS SURGERY, THE SURGEON DETERMINED AN ADDITIONAL IMPLANTATION WAS NECESSARY AT THE NEXT SUPERIOR VERTEBRAL SPACE. DURING THIS SURGERY (DATE UNK), THE COROENT INTERLOCK SCREW WAS IMPACTED BY THE NEWLY-PLACED IMPLANT SCREW. SUBSEQUENTLY THE INTERLOCK IMPLANT SCREW WAS NOTED TO BE BROKEN DURING A F/U EXAMINATION ON (B)(6) 2012. REVISION SURGERY OCCURRED (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE COROENT INTERLOCK INTERVERTEBRAL BODY FUSION DEVICE ODP NUVASIVE, INC. 6791712 BB2951

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention