BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINPLATE 14MM 31X24MM

    MDR report key: 2442561 · Received January 20, 2012

    Report

    Report Number
    3008657535-2012-00003
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    December 21, 2011
    Report Date
    January 20, 2012
    Manufacturer
    THEKEN SPINE, LLC
    Product Code
    OVD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY INDICATES THAT REVISION A OF THE SPIN PLATE IMPLANT WAS MODIFIED IN (B)(6) 2008 WHICH REQUIRED A CORRESPONDING FREEHAND LOCKER INSTRUMENT CHANGE. THE SURGEON HAD A REVISION A SPIN PLATE DESIGN AND WAS USING A REVISED FREEHAND LOCKER WHICH IS NOT COMPATIBLE. THE LIKELY ROOT CAUSE IS THAT THE OLD CONFIGURATION SPIN PLATE REVISION A WAS NOT COMPATIBLE WITH THE CURRENT FREEHAND LOCKER. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED INTEGRA CONSIDERS THE COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SPIN PLATE WAS NOT MFG CORRECTLY, THERE WAS NO PLACE TO SECURE THE T-HANDLE. THE SURGEON HAD TO REMOVE THE PEAK CAGE TO PLACE ANOTHER SPIN CAGE. A TEN MINUTE SURGERY DELAY AND NO HARM TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINPLATE 14MM 31X24MM VU-APOD OVD THEKEN SPINE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1