BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD C/D CLICKER MODEL

    MDR report key: 2848476 · Received November 20, 2012

    Report

    Report Number
    9680825-2012-00040
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THIS SPECIFIC LOT BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2004, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST BREAKAGE NOTIFIED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL HAS REQUESTED TO THE DISTRIBUTOR INVOLVED PATIENT'S DETAILS INCLUDING AN UPDATE ON THE CURRENT HEALTH CONDITION AND COPY OF THE PRE AND POST OPERATIVE X-RAYS AND THE DEVICE AVAILABILITY FOR THE TECHNICAL INVESTIGATION. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. ALTHOUGH THE CD UNIT REPLACEMENT IS TYPICALLY PERFORMED OUTSIDE THE OPERATIVE ROOM, GIVEN THE FEW INFORMATION PROVIDED IN THIS CASE, ORTHOFIX DECIDES TO REPORT IT AS A POTENTIAL PRODUCT PROBLEM AS IT LED TO A REINTERVENTION. AS SOON AS FURTHER INFORMATION WILL BECOME 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 INFORMATION PROVIDED BY THE DISTRIBUTOR INDICATES: SURGEON'S NAME: DR (B)(6); DATE OF SURGERY: (B)(6) 2012; EVENT DESCRIPTION: PER TERRITORY MANAGER, DURING THE WEEKEND OF (B)(6), THE CD UNIT BROKE AND WOULD NOT DISTRACT WHILE ON PATIENT. A NEW CD UNIT WAS PUT ON PATIENT ON (B)(6) 2012. NO ADVERSE EFFECTS FOR THE PATIENT. ON (B)(6) 2012, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: A NEW CD UNIT WAS PUT ON THE PATIENT'S FIXATOR IN REVISION SURGERY ON (B)(6) 2012. ALTHOUGH WE ONLY SWITCHED OUT THE PARTIES, THIS WAS DONE IN THE OPERATING ROOM. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA IN THE OPERATING ROOM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD C/D CLICKER MODEL STANDARD C/D CLICKER MODEL JDW ORTHOFIX SRL 50008 B04

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR