BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAL PEDICLE SCREW SYSTEM

    MDR report key: 1587522 · Received January 13, 2010

    Report

    Report Number
    1530901-2009-00027
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 14, 2009
    Report Date
    January 13, 2010
    Manufacturer
    THEKEN SPINE, LLC
    Product Code
    NKB
    PMA / PMN Number
    K070962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW SEPARATION COMPLAINTS WERE THE SEPARATION OCCURRED DURING THE PROCEDURE WERE A RESULT OF THE LOAD PLACED ON THE SCREWS BY THE SURGEONS, EITHER DURING COMPRESSION/DISTRACTION OF THE SCREW HEADS, OR BY ATTEMPTING TO ANGULATE THE SCREW HEADS IN EXCESS OF THE RECOMMENDED RANGE OF MOTION. PER THE PROJECT ENGINEER, EXAMINATION OF THE IMPLANT RETURNED WITH THIS COMPLAINT SHOWS EVIDENCE IN THE WAY THE COLLET FAILED OF OFF-AXIS OR LEVERING FORCES BEING APPLIED TO THE IMPLANT TO CAUSE FAILURE RATHER THAN PULL-OUT. THE DHR FOR THIS LOT OF SCREWS WAS EXAMINED, AND IT WAS COMPLETE. THERE WERE NO NONCONFORMANCES NOTED.

    Description of Event or Problem · 1

    THE SURGEON WAS ADJUSTING THE POLYAXIAL SCREW HEAD TO SEAT THE ROD AND THE HEAD BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAL PEDICLE SCREW SYSTEM SPINAL PEDICLE FIXATION SYSTEM NKB THEKEN SPINE, LLC 18-12-7545 W10214

    Patients

    Seq Age Sex Outcome Treatment
    1