BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXANO IO-FLEX MICROBLADE SHAVER

    MDR report key: 2034642 · Received February 16, 2011

    Report

    Report Number
    3006324586-2011-00004
    Event Type
    Other
    Date Received
    February 16, 2011
    Date of Event
    November 11, 2010
    Report Date
    February 15, 2011
    Manufacturer
    BAXANO, INC.
    Product Code
    HAE
    PMA / PMN Number
    K100958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE PT PRESENTED WITH RIGHT LEG NUMBNESS AND WEAKNESS. THE PT WAS SCHEDULED FOR POSTERIOR DECOMPRESSION AT L2/3, L3/4, AND L4/5. AFTER SUCCESSFUL DECOMPRESSION OF THE RIGHT L2/3 AND RIGHT L3/4 FORAMEN, THE SURGEON BEGAN DECOMPRESSION OF THE LEFT L3/4 USING A BAXANO 10 MM MICROBLADE SHAVER. AFTER APPROX 6 RECIPROCATIONS USING THE SHAVER, THE SURGEON NOTED A "POSSIBLE SNAP TIP OF SAP". THE PHYSICIAN STOPPED RECIPROCATIONS FOR THIS LEVEL AND PROCEEDED WITH BAXANO DECOMPRESSIONS ON THE LEFT AND RIGHT L4/5 FORAMEN WITH NO ISSUES. NO ADD'L TREATMENT WAS PERFORMED AND NO SEQUELAE WERE NOTED. THE DEVICE WAS NOT RETURNED FOR INSPECTION AS NO DEVICE MALFUNCTION OCCURRED. THE SURGEON DID NOT CONSIDER THIS TO BE A SERIOUS ADVERSE EVENT BECAUSE THERE WAS NO ADVERSE SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXANO IO-FLEX MICROBLADE SHAVER RONGEUR, MANUAL HAE BAXANO, INC. IO-MBS10SC 10091302

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other