BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE

    MDR report key: 2830337 · Received November 7, 2012

    Report

    Report Number
    MW5027574
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 8, 2012
    Manufacturer
    NUVASIVE, INC
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ELECTIVE L2-3 DISKECTOMY WITH INSERTION OF POLYETHERETHERKETONE SPACER FOR INTERBODY FUSION AND DEFORMITY CORRECTION OF DEGENERATIVE LUMBAR DISK DISEASE AND FOCAL SCOLIOSIS, L2-4 ON (B)(6) 2012. DURING THE PROCEDURE, WHILE POSITIONING THE SPACER, THE CAGE SPINAL PEEK WAS NOTED TO BE CRACKED. THE BROKEN FRAGMENTS WERE REMOVED. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVASIVE PART OF KIT CAGE SPINAL PEEK MAX NUVASIVE, INC COROENT LORDOTIC XL 8X18X45 RM0654

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other