BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERONAIL TITANIUM FIXED PROXIMAL SCREW

    MDR report key: 2833732 · Received November 7, 2012

    Report

    Report Number
    9680825-2012-00037
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL INVESTIGATION: A TECHNICAL EVAL OF THE BROKEN DEVICE USED WAS NOT PERFORMED AS THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR THE INVESTIGATION. UNFORTUNATELY, NO INFO ABOUT LOT INVOLVED IS AVAILABLE, THEREFORE IT IS NOT POSSIBLE TO PERFORM ANY TECHNICAL INVESTIGATION. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS ON THIS SPECIFIC DEVICE CODE, (B)(4). CLINICAL EVAL: A CLINICAL EVAL OF THE CASE WAS NOT PERFORMED AS NO INFO ON THE MEDICAL PROCEDURE, DIAGNOSIS AND X-RAYS HAVE BEEN MADE AVAILABLE. ORTHOFIX (B)(4) HAS REQUESTED TO THE LOCAL DISTRIBUTOR TO PROVIDE FURTHER INFO ON THE EVENT SUCH AS A PT DIAGNOSIS, DATE OF INITIAL SURGERY, DATE OF SCREW BREAKAGE, PT'S DETAILS, COPY OF THE OPERATIVE REPORTS, COPY OF THE PRE AND POST OPERATIVE X-RAYS, LOT OF THE DEVICE INVOLVED AND DEVICE AVAILABILITY FOR THE TECHNICAL INVESTIGATION. AS SOON AS FURTHER INFO ON THE EVENT WILL BECOME AVAILABLE, ORTHOFIX (B)(4) WILL FINALIZE THE INVESTIGATION AND PROVIDE YOU WITH THE F/U REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: THE BREAKAGE OF A VERONAIL LOCKING SCREW OCCURRED ON THE MOST PROXIMAL SCREW (CONVERGENT SCREWS) 2 MONTHS FROM THE APPLICATION. ON (B)(6) 2012, THE SURGEON REMOVED THE NAIL AND SCREWS, EXCEPT FOR THE DISTAL PART OF THE BROKEN SCREW THAT WAS LEFT IN THE PT'S HIP. THE PT FRACTURE WAS TREATED USING ANOTHER FIXATION DEVICE. THE PT IS IN GOOD HEALTH CONDITION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERONAIL TITANIUM FIXED PROXIMAL SCREW VERONAIL TITANIUM FIXED PROXIMAL SCREW HSB ORTHOFIX SRL 99-T79685 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention NO INFO HAVE BEEN MADE AVAILABLE.