BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 4144171 · Received April 28, 2014

    Report

    Report Number
    2032593-2014-00024
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 3, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K072605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED 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 CONCERNING THE SAME PATIENT SURGERY. THIS REPORT CONCERNS A MIDDLE SCREW (PRODUCT ID 11-3020-60) THAT WAS USED FOR THAT SURGERY. (SEE MFG REPORT NUMBER 2032593-2014-00021). IT WAS REPORTED DURING A L5-S1 ANTERIOR-POSTERIOR FUSION SURGERY, A MALIBU LARGE CROSSBAR BROKE WHILE BEING TIGHTENED WITH A TORQUE LIMITING SCREWDRIVER. THE SCREWS (TWO) THAT ATTACH THE CROSSBAR TO THE ROD WERE TIGHTENED FIRST. DURING TIGHTENING OF THE MIDDLE SCREW (THAT ADJUSTS THE LENGTH OF THE CROSSBAR) THE SCREW WAS SHEARED FROM THE CROSSBAR ASSEMBLY. THE SURGEON REMOVED THE CROSSBAR AND REPLACED IT WITH ANOTHER ONE OF THE SAME SIZE WITHOUT INCIDENT. THE PATIENT WAS NOT HARMED AND THE SURGERY WAS DELAYED BY APPROXIMATELY TWO MINUTES. ADDITIONAL INFORMATION REGARDING THE DEVICE WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253813 NONE KWP SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1