BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALIBU POLYACIAL SCREW 6.5 X 45MM

    MDR report key: 2440768 · Received January 31, 2012

    Report

    Report Number
    2032593-2012-00006
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 31, 2012
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2011 FOR A L5-S1 FUSION. AT A SIX MONTH FOLLOW UP APPOINTMENT, THE SURGEON NOTICED ONE SCREW WAS BROKEN. THE BROKEN SCREW DID NOT WARRANT IMMEDIATE REVISION SURGERY. AT A LATER TIME, THE SURGEON SCHEDULED A REVISION SURGERY FOR (B)(6) 2012. DURING THE REVISION SURGERY, THE SURGEON FOUND AN ADDITIONAL BROKEN SCREW. THE SURGEON PERFORMED FURTHER DECOMPRESSION AND RE-INSTRUMENTATION. THE BROKEN SCREWS WERE REMOVED WITHOUT INCIDENT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALIBU POLYACIAL SCREW 6.5 X 45MM MALIBU NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention