BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI BONE HEALING SYSTEM

    MDR report key: 3023683 · Received March 27, 2013

    Report

    Report Number
    0002242816-2013-00023
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 25, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED VIA MEDWATCH REPORT ((B)(4)). NO PRODUCT WAS RETURNED TO MANUFACTURER. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DEVICE MANUFACTURE DATE - UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE CLAIMS OF THE PATIENT ARE NOT VERIFIED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, ALLEGATIONS OF MEDWATCH THAT PT WAS "DENIED ACCESS TO ANYONE WHO MIGHT HAVE BEEN ABLE TO PROVIDE KEY INFO" ARE UNFOUNDED. ENGINEERING, MARKETING, AND LEGAL PERSONNEL ALONG WITH TWO COMPANY REPRESENTATIVES AND CUSTOMER CARE REPRESENTATIVE WERE ALL INVOLVED IN RESOLVING THE PATIENT'S COMPLAINTS AND ISSUES. ACCORDING TO THE MANUAL (1068012L REV B) ON PAGE 18, THE MANUAL RECOMMENDS THE FLX-5 COIL FOR "FEMUR" AND ON PAGE 19 BOTH FLX-4 AND FLX-5 COILS ARE APPLICABLE FOR "FEMUR." THE USE OF EITHER FLX-4 OR FLX-5 IS DEPENDENT ON THE PATIENT'S ANATOMY AND "DEPTH OR PENETRATION" REQUIRED FOR TREATMENT. DIRECT COMMUNICATIONS WITH THE PATIENT FROM VARIOUS COMPANY PERSONNEL PROVIDED THE PATIENT WITH ALL THE INFORMATION SHE REQUESTED.

    Description of Event or Problem · 1

    PER MEDWATCH REPORT (B)(4), PATIENT... WAS DIAGNOSED WITH A STRESS FRACTURE REQUIRING MEDICAL TREATMENT TO HER RIGHT FEMUR ("UNDERLYING INJURY") "THEREAFTER, PATIENT BEGAN RECEIVING TREATMENT OF THE UNDERLYING INJURY FROM A QUALIFIED MEDICAL PROVIDER." ON OR ABOUT (B)(6) 2012, PATIENT WAS PRESCRIBED THE USE OF THE BHS UNIT... AS PART OF THE TREATMENT FOR THE UNDERLYING INJURY". PATIENT HAS SUFFERED: PAIN, SUFFERING, AND INCONVENIENCE..." THE ALLEGATIONS OF THE COMPLAINT ARE UNVERIFIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126364 EBI BONE HEALING SYSTEM BHS, FLX-4 SYSTEM LOF EBI, LLC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S