BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE SPINOUS PROCESS PLATE SYSTEM

    MDR report key: 2380362 · Received November 14, 2011

    Report

    Report Number
    2031966-2011-00051
    Event Type
    Malfunction
    Date Received
    November 14, 2011
    Date of Event
    June 28, 2011
    Report Date
    November 14, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    PEK
    PMA / PMN Number
    K073278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO OTHER INFORMATION IS KNOWN WITH RESPECT TO PATIENT AGE, DIAGNOSIS, BONE INTEGRITY, SPINE LEVEL AFFECTED, NEED FOR ADDITIONAL INTERVENTION, ETC. THE REPORTED EVENT HAS NOT BEEN VERIFIED VIA RADIOGRAPHY OR OTHER MEANS. PRODUCT IDENTIFICATION IS PENDING. ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN IDENTIFIED. WHEN ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN, A SUBSEQUENT REPORT WILL BE FILED. REVIEW OF LABELING NOTES: "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..."

    Description of Event or Problem · 1

    A SPINOUS PROCESS PLATE WAS REPORTEDLY IMPLANTED (B)(6) 2011. THE PATIENT REPORTED INCREASING BACK PAIN DURING A FOLLOW-UP VISIT APPROXIMATELY 6 WEEKS FOLLOWING SURGERY. AT THAT TIME IT WAS DETERMINED THE PLATE HAD LOOSENED. NO ADDITIONAL INFORMATION HAS BEEN AVAILABLE TO INVESTIGATE FURTHER. IT IS UNKNOWN IF REVISION SURGERY HAD OCCURRED. PATIENT INFORMATION AND PRODUCT IDENTIFICATION HAS NOT BEEN AVAILABLE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE SPINOUS PROCESS PLATE SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS PEK NUVASIVE, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1