BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI BONE HEALING SYSTEM

    MDR report key: 3041115 · Received April 8, 2013

    Report

    Report Number
    0002242816-2013-00030
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NON-INVASIVE BONE GROWTH STIMULATION DEVICES HAVE BEEN AVAILABLE IN THE MARKET SINCE 1979 AND NO SIMILAR REPORTED INCIDENT WAS FOUND. THE USER'S MANUAL SPECIFICALLY STATES: "NOT FOR USE BY PATIENTS WHO ARE PREGNANT OR BECOMING PREGNANT" THE CLAIMS OF THE REPORTED INCIDENT REMAIN UNVERIFIED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. THE ALLEGATIONS OF THE COMPLAINT ARE UNVERIFIED. NOTE: THE USER'S MANUAL CONTAINS THE FOLLOWING WARNING AGAINST USAGE OF THE SYSTEM DURING PREGNANCY: "NOT FOR USE BY PATIENTS WHO ARE PREGNANT OR BECOMING PREGNANT" "USE OF THE EBI BONE HEALING SYSTEM STIMULATOR ON PREGNANT PATIENTS HAS NOT BEEN EVALUATED; THEREFORE, IT IS NOT RECOMMENDED IN THESE CASES." "USE OF THE BONE HEALING SYSTEM ON PREGNANT PATIENTS HAS NOT BEEN EVALUATED THEREFORE, IT IS NOT RECOMMENDED IN THESE CASES. IF YOU BECOME PREGNANT, NOTIFY YOUR PHYSICIAN IMMEDIATELY." NO FURTHER INFORMATION HAS BEEN RECEIVED. NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    PATIENT REPORTED ALLEGED INJURY TO HER CHILD AFTER USING BHS UNIT IN 2008. ACCORDING TO THE PATIENT, SHE WAS UNAWARE THAT SHE WAS (B)(6) PREGNANT WHILE USING THE DEVICE. THE PATIENT ALLEGES THAT THE USAGE OF THE DEVICE DURING HER PREGNANCY HAS SUBSEQUENTLY LED TO HER CHILD BEING DIAGNOSED WITH ENAMEL HYPOPLASIA. THIS REPORT IS BASED UPON ALLEGATIONS BY PATIENT'S CLAIM AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143003 EBI BONE HEALING SYSTEM MODEL 2001 BHS, CONTROLLER LOF EBI, LLC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability