BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALIBU POLYAXIAL SCREWS 6.5 X 45MM

    MDR report key: 3975737 · Received July 9, 2014

    Report

    Report Number
    2032593-2014-00035
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 18, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K072605
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF TWO REPORTS (SEE MFG REPORT NUMBER 2032593-2014-00034) CONCERNING THE SAME PATIENT SURGERY. THIS REPORT CONCERNS MALIBU POLYAXIAL SCREWS 6.5 X 45MM (PRODUCT ID 12-6545). IT WAS REPORTED A 2 LEVEL LUMBAR FUSION WITH MALIBU WAS PERFORMED ON (B)(6) 2013. ON AN UNKNOWN DATE, FOLLOWING THE INITIAL SURGERY, THE SCREWS BREAKAGE WAS SEEN ON X-RAY. THE SCREWS WERE REMOVED ON (B)(6) 2014 DUE TO BREAKAGE AT S1 LEVEL. THE DEVICES WERE REPLACED BY A COMPETITOR PRODUCT. THE PRECISE NUMBER OF SCREWS INVOLVED WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BY INTEGRA. ON (B)(6) 2014 THE SURGEON INDICATED HE DID NOT WANT TO PROVIDE ANY FURTHER INFORMATION. THE BROKEN MALIBU PRODUCTS WERE NOT AVAILABLE FOR INVESTIGATION. THEY WERE "GIVEN TO THE PATIENT". THE PATIENT CURRENT CONDITION WAS REPORTED AS "DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400761 MALIBU POLYAXIAL SCREWS 6.5 X 45MM MALIBU NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention 3 SCREWS (REFERENCE 12-6540)| OTHER MALIBU DEVICES IMPLANTED:| 1 ROD 50MM (REFERENCE 12-1050)| 1 ROD 60MM (REFERENCE 12-1060)| 6 MALIBU CAPS