BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALIBU POLYAXIAL SCREW 6.5 X 45MM

    MDR report key: 2440755 · Received January 31, 2012

    Report

    Report Number
    2032593-2012-00003
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 9, 2011
    Report Date
    January 31, 2012
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 THE PATIENT HAD L5-S1 FUSION IN MARCH OF 2011. AT A SIX MONTH FOLLOW UP APPOINTMENT THE SURGEON NOTICED ONE SCREW WAS BROKEN. THE BROKEN SCREW DID NOT WARRANT IMMEDIATE REVISION SURGERY. THE SURGEON LATER SCHEDULED 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 SUCCESSFULLY AND THE REVISION SURGERY WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention