BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA ZS TRANSITION SCREW

    MDR report key: 4380049 · Received December 30, 2014

    Report

    Report Number
    9617297-2014-00001
    Event Type
    Injury
    Date Received
    December 30, 2014
    Date of Event
    August 1, 2013
    Report Date
    September 14, 2013
    Manufacturer
    U&I CORP.
    Product Code
    MNI
    PMA / PMN Number
    K071880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE REPORT THIS EVENT FOLLOWING BY THE MDR REGULATION OF FDA. THE EVENT WAS OCCURRED AT A HOSPITAL IN (B)(6). WE RECEIVED ADDITIONAL INFO ON (B)(6) 2014 THAT WERE AGE OF THE PT, FUSION CONDITION AFTER THE FIRST SURGERY, PT'S ACTIVITY, AND SHORT DESCRIPTION ON IMAGE TESTS AND MAGNETIC RESONANCE SCANNING. WE WERE INFORMED THAT PT'S CONDITION GOT BETTER AFTER RE-INTERVENTION AND PAIN WAS REDUCED.

    Description of Event or Problem · 1

    A PT WAS OPERATED WITH THE DTO SYSTEM IN LEVEL L4-S1 (L4L5 DYNAMIC, L5-S1 RIGID) ON (B)(6) 2013. AFTER SEVERAL MONTHS, THE PT HAD PAIN AND OBSERVATION WAS OBTAINED BY X-RAY THAT THE BAR ON THE RIGHT SIDE WAS OUT OF THE SCREW HEAD. THUS, IT WAS DECIDED TO PERFORM RE-INTERVENTION. ON (B)(6) 2013 THE SURGEON FOUND THAT THE SCREW OF TRANSITION OF DTO (SDA6045) WAS BROKEN AND THE HEAD OF THE SCREW WAS SEPARATED FROM THE BODY. DURING THE EXTRACTION, ONLY SCREW HEAD WAS POSSIBLE TO BE EXTRACTED BUT NOT THE BODY AS IT WAS IN THE BONE. THE SURGEON SUBSTITUTES THE SCREW DYNESYS L4BY OPTIMA SCREW AND CLOSE THE CONSTRUCTION WITH THE SCREW L5 ALREADY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858423 OPTIMA ZS TRANSITION SCREW SPINAL FIXATION SYSTEM MNI U&I CORP. A09L068

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention