BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET EBI BONE HEALING SYSTEM SFLX 4 COIL

    MDR report key: 6472420 · Received April 7, 2017

    Report

    Report Number
    0002242816-2017-00013
    Event Type
    Injury
    Date Received
    April 7, 2017
    Report Date
    April 7, 2017
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP790002
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE ITEM WAS PERFORMED. THE SYSTEM WAS RECEIVED IN SHIPPING SPARE PART BOX. PART RECEIVED SEEMS TO BE IN GOOD PHYSICAL CONDITION FROM THE COSMETIC/VISUAL POINT OF VIEW. REVIEW OF CONTROLLER DATA DOWNLOADED WAS PERFORMED AND THE TREATMENT HOURS INDICATES THE UNIT TREATED FOR 85 HOURS (TREATMENT PERIOD 17 DAYS). NO ABNORMAL CONDITION REPORTED ON DEVICE HISTORY RECORDS. A VISUAL INSPECTION OF THE SYSTEM WAS PERFORMED AND NO EXPOSED WIRING WAS OBSERVED. THE SYSTEM WAS FUNCTIONALLY TESTED AND WAS FOUND TO OPERATE AS INTENDED. NO PHYSICAL AND/OR DEVICE FUNCTION CONDITION COULD BE FOUND THAT COULD BE CONSIDERED AS A CAUSAL FACTOR FOR THE REPORTED COMPLAINT. THE REPORTED CONDITION IS RELATED TO CLINICAL FACTORS BEYOND THE SCOPE OF THE DEVICE INVESTIGATION COVERED IN THE COMPLAINT INVESTIGATION. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT. REPORT ONE OF TWO IS REPORTED ON MFR #0002242816-2017-00012.

    Additional Manufacturer Narrative · 1

    PMA/501 (K) #P790002/S026. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT. REPORT ONE OF TWO IS REPORTED ON MFR #0002242816-2017-00012.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE COIL BATCH HISTORY SHOWS THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THE PATIENT USED THE UNIT FOR ABOUT A MONTH AND DEVELOPED A HUGE RASH WITH BLISTERS ON THE SKIN OF HIS LEG IN THE OPENING OF THE COIL. THE PATIENT SAW THE DOCTOR ABOUT THREE TO FOUR WEEKS PRIOR TO (B)(6) 2017. THE DOCTOR TOLD THE PATIENT TO DISCONTINUE USING THE DEVICE BECAUSE OF THE RASH. THE PATIENT IS IN THE HOSPITAL AND HAD ANOTHER SURGERY. MORE INFORMATION WAS REQUESTED ABOUT THE HOSPITALIZATION AND EVENT BUT NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254329 BIOMET EBI BONE HEALING SYSTEM SFLX 4 COIL STIMULATOR, BONE GROWTH, NON-INVASIVE COIL LOF EBI, LLC. N/A 16314

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R