BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBEX SPINAL SYSTEM IMPLANTS AND INSTRUMENTS

    MDR report key: 2468131 · Received February 24, 2012

    Report

    Report Number
    0002242816-2012-00019
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 7, 2012
    Manufacturer
    EBI, LLC
    Product Code
    NKB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL EXAMINATION OF THE RETURNED GUIDES CONFIRMED THE REPORTED EVENT. THE DHR, RISK ANALYSIS, AND THE DESIGN FMECA WERE REVIEWED AND IT WAS DETERMINED THAT THE REPORTED EVENT IS ADEQUATELY IDENTIFIED. THE PROBABLE UNDERLYING ROOT CAUSE FOR THE REPORTED EVENT IS INSUFFICIENT USAGE OF SEALANT. THE MANUFACTURER IS AWARE OF THE REPORTED EVENT AND HAS TAKEN STEPS TO MITIGATE FUTURE OCCURRENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE INSTRUMENTS MALFUNCTIONED RESULTING IN A DELAY OF OVER THIRTY MINUTES.PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBEX SPINAL SYSTEM IMPLANTS AND INSTRUMENTS IBEX STD. 70 DEG INSERTER NKB EBI, LLC N/A 088295

    Patients

    Seq Age Sex Outcome Treatment
    1