BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IO-FLEX

    MDR report key: 3533257 · Received December 23, 2013

    Report

    Report Number
    3006324586-2013-00010
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Date of Event
    October 9, 2013
    Report Date
    November 13, 2013
    Manufacturer
    BAXANO, INC.
    Product Code
    HAE
    PMA / PMN Number
    K100958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON DECIDED INTERVENTION WAS NOT REQUIRED TO PREVENT PERMANENT IMPAIRMENT. THEREFORE, THE REPORTABLE TYPE IS "OTHER: MALFUNCTION PREVIOUSLY REPORTED." MULTIPLE PROBES WERE USED DURING THE PROCEDURE. IT IS UNCLEAR WHICH DEVICE IS THE ONE IN QUESTION. THE FOLLOWING PROBES WERE USED DURING THE PROCEDURE. PRODUCT INFORMATION: BRAND NAME: BAXANO IO-FLEX CONTRA PROBE: MODEL/CATALOG #: IO-CP45, LOT #: 101469, EXPIRATION DATE: 04/2015, DEVICE MANUFACTURE DATE: 04/12/2013. BRAND NAME: BAXANO IO-FLEX CONTRA PROBE: MODEL/CATALOG #: IO-CP45, LOT #: 100630, EXPIRATION DATE: 05/2014, DEVICE MANUFACTURE DATE: 04/30/2012. BRAND NAME: BAXANO IO-FLEX IPSI PROBE: MODEL/CATALOG #: IO-IP, LOT #: 101703, EXPIRATION DATE: 07/2015, DEVICE MANUFACTURE DATE: 06/25/2013. BRAND NAME: BAXANO IO-FLEX IPSI PROBE: MODEL/CATALOG #: IO-IP, LOT #: 101223, EXPIRATION DATE: 12/2013, DEVICE MANUFACTURE DATE: 12/17/2012. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE TIP OF THE INSTRUMENT BROKE AND WAS LODGED IN THE BONE. THE SURGEON ASSESSED THE SITUATION AND CHOSE TO LEAVE THE TIP BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673755 IO-FLEX ACCESSORY TO MANUAL RONGEUR HAE BAXANO, INC. IO-CP45 101469

    Patients

    Seq Age Sex Outcome Treatment
    1 Other