BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXANO IO-FLEX SYSTEM

    MDR report key: 2651986 · Received July 2, 2012

    Report

    Report Number
    3006324586-2012-00010
    Event Type
    Other
    Date Received
    July 2, 2012
    Date of Event
    September 20, 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 100032, (05/27/2011 / 2013-05). K113533 SURGICAL NERVE STIMULATOR/LOCATOR, BAXANO IO-FLEX WIRE, MODEL-CATALOG NO. IO-NCW, LOT 100032, (05/27/2011 / 2013-05). K100958 RONGEUR, MANUAL, BAXANO IO-FLEX DISTAL HANDLE, MODEL-CATALOG NO. IO-DH, LOT 100057, (09/21/2011 / 2013-06). K100958 RONGEUR, MANUAL, BAXANO IO-FLEX MICROBLADE SHAVER, MODEL-CATALOG NO. IO-MBS 7.5SC, LOT 100047, (06/15/2011 / 2012-05). K100958 RONGEUR, MANUAL, BAXANO IO-FLEX MICROBLADE SHAVER, MODEL-CATALOG NO. IO-MBS 5.5, LOT 100046, (06/15/2011 / 2012-06). K102594 BAXANO IO-FLEX IPSI IRRIGATION CANNULA, MODEL-CATALOG NO. IO-IC, LOT 11030903, (03/21/2011 / 2011-09).

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT (B)(6) UNDERWENT DECOMPRESSIVE SURGERY WITH BAXANO IO-FLEX TOOLS VIA BILATERAL DISC LEVEL PASSES AT L4/5 WITH A DISC LEVEL PASS AT LEFT L5/S1. THE PT WAS DISCHARGED THE NEXT DAY. AT TWO WEEKS POST-SURGERY, PT WAS REPORTED TO BE MUCH BETTER WITH SOME PAIN IN THE LEFT GROIN AND THIGH. AT ONE MONTH POST-SURGERY, A WOUND INFECTION WAS DIAGNOSED (CULTURE WAS POSITIVE FOR (B)(6)). DRAINAGE WAS PERFORMED AND LEVAQUIN, BACTRIN, RIFAMYCIN, AND CLINDAMYCIN WERE PRESCRIBED. AT 3 MONTHS POST-SURGERY, THE WOUND INFECTION WAS FULLY RESOLVED.

    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 100056

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other