BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIBIAL STABILIZING ROD M6

    MDR report key: 3177047 · Received June 11, 2013

    Report

    Report Number
    9680825-2013-00013
    Event Type
    Other
    Date Received
    June 11, 2013
    Date of Event
    April 18, 2013
    Report Date
    August 12, 2013
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DOES NOT MEET THE REQUIREMENTS OF MANDATORY REPORT, AS THERE ARE NO ADVERSE EFFECTS TO THE PT. FOLLOWING THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATIONS: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON 01/15/2008, ORTHOFIX SRL DECIDES TO REPORT THIS KIND OF EVENT ON A VOLUNTARY BASIS. ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE CODE 174031 LOT NUMBER G005 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED ON 2007, WAS COMPRISED ON 30 STABILIZERS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE. TECHNICAL EVAL: THE TECHNICAL EVAL ON THE RETURNED DEVICE IS CURRENTLY ON-GOING. CLINICAL EVAL: THE INFORMATION AVAILABLE ON THE CASE WAS SENT TO OUT MEDICAL EVALUATOR. A PRELIMINARY CLINICAL EVAL WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVAL WILL BE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW-UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION PROVIDED BY THE DISTRIBUTOR INDICATED: WHEN LOOSENING THE STABILIZER FOR DISASSEMBLY, THE CONICAL THREADED PORTION IS BROKEN AND STUCK IN THE NAIL IN THE PT. NO ADVERSE EFFECTS TO PT. THE SURGERY WAS COMPLETED WITH THE USED DEVICE. NO CLINICALLY RELEVANT INCREASE OF THE SURGERY TIME. NO ADDITIONAL SURGERY REQUIRED. COPY OF THE OPERATIVE REPORT AND X-RAYS ARE NOT AVAILABLE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263650 TIBIAL STABILIZING ROD M6 TIBIAL STABILIZING ROD M6 HSB ORTHOFIX SRL 174031 G005

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other NO INFORMATION HAS BEEN MADE AVAILABLE| NO INFORMATION HAS BEEN MADE AVAILABLE