BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOTITE CORTICAL SCREW, STERILE

    MDR report key: 1719456 · Received May 14, 2010

    Report

    Report Number
    9680825-2010-00004
    Event Type
    Other
    Date Received
    May 14, 2010
    Report Date
    May 14, 2010
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K974186
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DOES NOT MEET THE REQUIREMENTS OF MANDATORY REPORT, AS THERE ARE NO ADVERSE EFFECTS ON PT. FOLLOWING THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON (B)(4) 2008, ORTHOFIX (B)(4) DECIDES TO REPORT THIS KIND OF EVENTS. ON A VOLUNTARY BASE. THE BROKEN SCREW, RECEIVED ON (B)(6) 2010 WAS EXAMINED BY ORTHOFIX QUALITY ENGINEERING DEPARTMENT AND IMMEDIATELY SENT TO AN EXTERNAL LABORATORY FOR CHEMICAL, MECHANICAL, AND METALLURGICAL AND FAILURE ANALYSIS. THE TECHNICAL ANALYSIS PERFORMED ON THE RETURNED DEVICE, WHICH EVIDENCED ITS COMPLIANCE TO ORTHOFIX DESIGN SPECIFICATIONS, AND THE X-RAY EVALUATION MADE BY EXTERNAL MEDICAL EVAL, CONFIRMED THAT THE EVENT WAS NOT PRODUCT RELATED. ANYWAY, A FRAGMENT OF THE SCREW WAS LEFT INSIDE THE PT, AS IT WAS DEEMED THE BEST SURGICAL CHOICE BY THE SURGEON. THIS THE REASON FOR THIS VOLUNTARY REPORTING. FOR YOUR INFO, ORTHOFIX HISTORICAL RECORDS INDICATE THAT THE DEFECT RATE DURING THE PERIOD OF TIME FROM (B)(4) 2004 UP TO DATE IS (B)(4) (BONE SCREWS DAF COATED). ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET.

    Description of Event or Problem · 1

    EIGHT WEEKS AFTER THE OPERATIVE PROCEDURE, HIGH TIBIAL OSTEOTOMY, THE TIP OF ONE OF THE HA COATED SCREWS IN THE METAPHYSEAL AREA HAD BROKEN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOTITE CORTICAL SCREW, STERILE OSTEOTITE CORTICAL SCREW, STERILE JDW ORTHOFIX SRL 99-60141 IT934454

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR