BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2045613 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00035
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    August 2, 2002
    Report Date
    October 23, 2002
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: USER ERROR - POOR TECHNIQUE IN IMPLANTING. THE IMPLANTING SURGEON, DR ACKNOWLEDGED THAT HE IMPROPERLY PLACED THE DEVICE INITIALLY, LEAVING A PORTION OF THE THREADED AREA OF THE DEVICE ACROSS A JOINT SPACE. DEVICE WAS REMOVED AND PT WAS FINE. INITIALLY, IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED. DEVICE EVAL: THE RETURNED DEVICE WAS VISUALLY INSPECTED. THE SCREW PORTION OF THE IMPLANT WAS ENTIRELY BROKEN OFF OF THE REST OF THE DEVICE.

    Description of Event or Problem · 1

    POST OPERATIVE FOLLOW UP VISIT AT THREE WEEKS REVEALED UNDER X-RAY THAT ONE 3.5MM DEVICE HAD BROKEN, HOWEVER, FUSION APPEARED TO BE HEALING NORMALLY. HAVING BEEN INFORMED OF THE PT'S ALLERGY TO STAINLESS AND TITANIUM PRIOR TO SURGERY. THE SURGEON SCHEDULED THE REMOVAL OF THE IMPLANTS TO COINCIDE WITH AN ADDITIONAL OSTEOTOMY OF THE CUBOID ON (B)(6) 2002. ALL DEVICES FROM THE AUGUST SURGERY WERE REMOVED WITHOUT INCIDENT. THE BROKEN SCREW DID NOT AFFECT PT HEALING OR REQUIRE ADDITIONAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW MRW INTERVENTIONAL SPINE, INC. SMCD-35-4050S 032802-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention