BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET EBI BONE HEALING SYSTEM

    MDR report key: 6004914 · Received October 6, 2016

    Report

    Report Number
    0002242816-2016-00031
    Event Type
    Injury
    Date Received
    October 6, 2016
    Report Date
    August 18, 2016
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP790002
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. THE REASON FOR THE LATE REPORT IS HUMAN ERROR.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. THE PRODUCT WAS RECEIVED IN A SHIPPING BAG APPEARING TO BE IN GOOD PHYSICAL CONDITION. THE DEVICE HISTORY RECORDS WERE REVIEWED IN THE EVALUATION AND NO ABNORMAL CONDITION WAS REPORTED. THE PRODUCT WAS FUNCTIONALLY TESTED AND OPERATED WITHIN SPECIFICATION. THEREFORE, THE COMPLAINT IS NOT CONFIRMED. THE MOST-LIKELY CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED BECAUSE THE PRODUCT FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE BONE HEALING SYSTEM WAS RETURNED BECAUSE THE SYSTEM "WAS TOO HEAVY AND WHEN THE COIL WOULD SLIDE OFF OF THE FOOT, IT WOULD TUG ON THE HEALING WOUND." THE PATIENT WAS SWITCHED TO AN ORTHOPAK UNIT BECAUSE IT WAS EASIER TO PLACE THE ELECTRODES ON THE OUTSIDE OF THE WOUND AND THEREFORE NOT INTERFERE WITH THE WOUND HEALING. IT IS REPORTED THE PATIENT IS DOING WELL WITH THE ORTHOPAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654752 BIOMET EBI BONE HEALING SYSTEM BONE STIMULATOR LOF EBI, LLC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other