BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXANO IO-FLEX SYSTEM

    MDR report key: 2651987 · Received July 2, 2012

    Report

    Report Number
    3006324586-2012-00011
    Event Type
    Other
    Date Received
    July 2, 2012
    Date of Event
    October 31, 2011
    Report Date
    July 2, 2012
    Manufacturer
    BAXANO, INC.
    Product Code
    HAE
    PMA / PMN Number
    K100958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IO-FLEX SYSTEM PRODUCT INFO & 510 (K) # (BRAND NAME, COMMON NAME, MODEL-CATALOG NO., LOT NO., MFG DATE/EXPIRY DATE): K110696 SURGICAL NERVE STIMULATOR/LOCATOR, BAXANO IO-FLEX NEURO CHECK, MODEL-CATALOG NO. IO-NCW, LOT 100163, (09/06/2011 / 2013-08). K113533 SURGICAL NERVE STIMULATOR/LOCATOR, BAXANO IO-FLEX WIRE, MODEL-CATALOG NO. IO-NCW, LOT 100163, (09/06/2011 / 2013-08). K100958 RONGEUR, MANUAL, BAXANO IO-FLEX DISTAL HANDLE, MODEL-CATALOG NO. IO-DH, LOT 100174, (09/12/2011 / 2013-09). K100958 RONGEUR, MANUAL, BAXANO IO-FLEX MICROBLADE SHAVER, MODEL-CATALOG NO. IO-MBS 10SC, LOT 11040703, (04/21/2011 / 2012-04). K102594 BAXANO IO-FLEX IPSI IRRIGATION CANNULA, MODEL-CATALOG NO. IO-IC, LOT 100175 (09/12/2011 / 2012-03).

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT (B)(6) ( MALE) UNDERWENT DECOMPRESSIVE SURGERY WITH BAXANO IO-FLEX TOOLS VIA UNILATERAL RIGHT DISC LEVEL PASS AT L4/5. THE PT WAS DISCHARGED THE SAME DAY. AT ONE WEEK POST-SURGERY, PT WAS SORE WITH GAIT THAT WAS ANTALGIC AND SLOW. AN INFECTION AT THE INCISION WAS DIAGNOSED. BACTRIN, CLINDAMYCIN AND A PAIN PATCH WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXANO IO-FLEX SYSTEM RONGEUR, MANUAL, BAXANO IO-FLEX PROBE HAE BAXANO, INC. IO-IP90 100140

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other