BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING CAP 8.0+

    MDR report key: 2440766 · Received January 31, 2012

    Report

    Report Number
    2032593-2012-00005
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 31, 2012
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON RE-OPERATED DUE TO A DEEP WOUND INFECTION. IT DID NOT HAVE ANYTHING TO DO WITH THE IMPLANTS. IT WAS NOTED THAT THE LOCKING CAPS ON THE ILIAC POLYAXIAL SCREWS WERE LOOSE. THE SURGEON RE-TORQUED THE LOCKING CAPS. DURING SURGERY THE SURGEON INSPECTED ALL CONNECTIONS AND TIGHTENED THEM AS A PRECAUTION. THE WOUND WAS IRRIGATED AND SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. ADDITIONAL INFORMATION WAS STATED BY THE REPORTER AT A LATER DATE; "THE SURGEON WAS NOT SURE IF THERE WAS AN INFECTION AT FIRST THEN THE SURGEON REPORTED NO INFECTION." "THE SURGEON HAS NO OTHER ISSUES TO REPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING CAP 8.0+ MALIBU NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention