BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0X9MM FOSSA X-DR SCREW

    MDR report key: 5396116 · Received January 28, 2016

    Report

    Report Number
    0001032347-2016-00052
    Event Type
    Injury
    Date Received
    January 28, 2016
    Date of Event
    July 1, 2015
    Report Date
    January 20, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK910038
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED TMJ PARTS WERE EVALUATED FOR THE COMPLAINT OF A REVISION DUE TO HETEROTOPIC BONE GROWTH. THE PARTS WERE VISUALLY INSPECTED AND FOUND IN GOOD WORKING CONDITION. THE PARTS SHOW NO SIGNS OF MANUFACTURING DEFECTS AND NO MALFUNCTION WAS REPORTED. THE COMPLAINT CANNOT BE VERIFIED AS THE PARTS WERE FOUND IN WORKING CONDITION AND EXPLANTED DUE TO THE PATIENTS CONDITION OF HETEROTOPIC BONE GROWTH. THE IFU (INSTRUCTIONS FOR USE) WARNS OF HETEROTOPIC BONE GROWTH AS AN ADVERSE EVENT FOR THIS SURGERY. THE MOST LIKELY CAUSE OF THE COMPLAINT IS PATIENTS CONDITION. THE DEVICE EVALUATION IDENTIFIED TWO ADDITIONAL SCREW PART NUMBERS, THEREFORE THIS REPORT WAS SUBMITTED; SEE ALSO 1032347-2016-00051. SEE SUPPLEMENTAL REPORTS 1032347-2015-00338-3, 1032347-2015-00339-3, 1032347-2015-00340-3 AND 1032347-2015-00341-3.

    Description of Event or Problem · 1

    A TMJ REVISION SURGERY WAS IDENTIFIED THROUGH THE RECEIPT OF TMJ TRACKING CARDS. ON (B)(6) 2010 A BIOMET JOINT WAS IMPLANTED ON THE LEFT SIDE ONLY. IT IS REPORTED THE PATIENT WAS EXPERIENCING SOME DISCOMFORT, THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 AND THE JOINT WAS REPLACED WITH A NEW BIOMET JOINT. THE SALES ASSOCIATE CONFIRMED THE REASON FOR THE REVISION WAS DUE TO HETEROTOPIC BONE GROWTH. AFTER THE BONE WAS REMOVED THE SURGEON WAS ABLE TO IMPLANT A NEW PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54521 2.0X9MM FOSSA X-DR SCREW SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R