BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ. X-CONN. MEDIUM 45-60.5MM

    MDR report key: 2012165 · Received February 1, 2011

    Report

    Report Number
    1530901-2011-00004
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 29, 2010
    Report Date
    February 1, 2011
    Manufacturer
    THEKEN SPINE
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE REPORTER STATED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL SURGERY PROCEDURE ON VERTEBRAE L5-S1 USING THE CORAL SPINAL SYSTEM, A MEDIUM ADJUSTABLE CONNECTOR BROKE. AFTER TIGHTENING THE SET SCREWS, THE SURGEON DISTRACTED THE CAM ON THE NONADJUSTABLE SIDE WITH NO PROBLEM, BUT WHEN HE DISTRACTED THE ADJUSTABLE SIDE THE CAM NEVER LOCKED DOWN. THE SURGEON REMOVED THE BROKEN CONNECTOR WHICH IS AVAILABLE FOR QUALITY INSPECTION. ANOTHER MEDIUM ADJUSTABLE CONNECTOR IN THE TRAY WAS USED, WHICH WORKED SATISFACTORILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJ. X-CONN. MEDIUM 45-60.5MM CORAL NKB THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1