BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TL PLUS HALF RING 180MM

    MDR report key: 3842643 · Received May 16, 2014

    Report

    Report Number
    9680825-2014-00013
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ORTHOFIX SRL
    Product Code
    LXT
    PMA / PMN Number
    K941048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 THE DEVICE CODE (B)(4), LOT 1207128 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2012, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN RELEASED TO THE MARKET ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THE DEVICE CODE (B)(4). TECHNICAL EVAL: THE RETURNED DEVICE RECEIVED ON (B)(4) 2014, IS CURRENTLY UNDER TECHNICAL EVAL. MEDICAL EVAL: THE INFO AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVAL WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVAL WILL BE AVAILABLE. AS SOON AS FURTHER INFO AND/OR THE RESULTS OF THE TECHNICAL EVAL 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 INFO PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL; SURGEON NAME: (B)(6); DATE OF SURGERY: (B)(6) 2014; BODY PART TO WHICH DEVICE WAS APPLIED: USED AS ARCH OVER FOOT PLATE; SURGERY DESCRIPTION: FRACTURE TREATMENT; PT'S INFO: (B)(6) APPROX YEARS FEMALE; PROBLEM OBSERVED INTO TREATMENT. EVENT DESCRIPTION: THE CORNER OF THE HALF RING BROKE AWAY (SNAPPED) WHILE PT WAS 6 WEEKS INTO HER TREATMENT. PT HAD TO HAVE ANOTHER HALF RING FITTED (B)(6) 2014 AS THEY WERE USING THIS AS THE ARCH OVER THE DOUBLE AND SINGLE ROW FOOT PLATES. THE COMPLAINT REPORT FORM INDICATES: NO ADVERSE EFFECTS TO PT; THE SURGERY WAS NOT COMPLETED WITH USED DEVICE; NO CLINICALLY RELEVANT INCREASE OF THE PROCEDURE TIME; AN ADDITIONAL SURGERY WAS REQUIRED; COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE; COPIES OF THE X-RAYS ARE NOT AVAILABLE; INFO ON PT CURRENT HEALTH CONDITION IS NOT AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293020 TL PLUS HALF RING 180MM TL PLUS HALF RING 180MM LXT ORTHOFIX SRL 56-11650 1207128

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention