BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

    MDR report key: 19508956 · Received June 11, 2024

    Report

    Report Number
    0002242816-2024-00077
    Event Type
    Injury
    Date Received
    June 11, 2024
    Report Date
    October 10, 2024
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    UDI-DI
    00812301020218
    PMA / PMN Number
    P850022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS - D1: BRAND NAME, D2: COMMON DEVICE NAME, D4: MODEL NUMBER, D8-9: RETURNED TO MANUFACTURER DATE, G4: PMA/510(K) #, H5, H6: DEVICE CODE, IMPACT CODE, COMPONENT CODE ADDITIONAL INFORMATION - B4: DATE OF THIS REPORT, B5: ADDITIONAL NARRATIVE, G3: DATE RECEIVED BY MANUFACTURER, H4: DEVICE MANUFACTURE DATE THE SPINALPAK ASSEMBLY WAS RECEIVED FOR EVALUATION, BUT DUE TO THE NATURE OF THE COMPLAINT AND THE INFORMATION PROVIDED WITHIN THE COMPLAINT FILE, ONLY THE SPINALPAK STIMULATOR WAS EVALUATED. A VISUAL INSPECTION OF THE CUSTOMER-RETURNED PRODUCT WAS PERFORMED. INCLUDED WAS ONE SPINALPAK STIMULATOR PART NO. 1067717 WITH SERIAL NUMBER (B)(6) RECEIVED IN A SHIPPING BOX. THE PART RECEIVED LOOKS TO BE IN GOOD CONDITION FROM THE VISUAL/COSMETIC POINT OF VIEW. THE SPINALPAK STIMULATOR COMPLIANCE DATA WAS DOWNLOADED ON AUGUST 6, 2024. THE COMPLIANCE DATA INDICATES THE UNIT TREATED FOR 1 DAYS 17 HOURS AND 54 MINUTES. REVIEW OF THE DHR INDICATES THAT UNIT WAS MANUFACTURED ON SEPTEMBER 12, 2019. THERE WERE NO NON-CONFORMANCES OR DEVIATIONS REPORTED ON THE DHR. THE SP UNIT RAN BURN-IN STAND-ALONE ¿BATTERY¿ ONLY FOR MORE THAN 24 HOURS WITH NO PROBLEM. THE MEASURED OUTPUT PERIOD WAS 15.4 USEC (SPECIFICATION - OUTPUT PERIOD FROM 15.2USEC ¿ 18.5USEC) ¿¿PASS¿. THE MEASURED OUTPUT AMPLITUDE WAS 5.6 VPP (SPECIFICATION - OUTPUT AMPLITUDE FROM 5.4VPP ¿ 6.4VPP) ¿¿PASS". ALL TESTS/INSPECTIONS WERE COMPLETED USING TEKTRONIX OSCILLOSCOPE ID OS-C001066 WITH CALIBRATION DUE ON APRIL 23, 2025; AND TF1930 S/N (B)(6) WITH A CALIBRATION DUE DATE OF FEBRUARY 15, 2025. TEST/INSPECTIONS WERE COMPLETED BY THE QUALITY DEPARTMENT ON AUGUST 7, 2024. REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER AND THE FINDINGS FROM THE INVESTIGATION INDICATED THAT NO PHYSICAL AND/OR DEVICE FUNCTIONAL CONDITION COULD BE FOUND THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT OF "PAIN". NO FAILURE AND/OR FAULT CONDITION COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. REVIEW OF COMPLAINT HISTORY IDENTIFIED (30) TOTAL COMPLAINTS FROM (MAY 13, 2023) TO (MAY 13 2024) FOR PN (1067716, 1067717) AND EVENTS RELATED TO (PAIN). KEYWORD SEARCH CRITERIA: (COMPLAINT CODE: MEDICAL: PAIN) THE SEARCH COULD NOT BE SPECIFIED FURTHER BECAUSE THE MAIN COMPLAINT WAS PAIN. THE FAILURE WAS NOT CONFIRMED FOR THE REPORTED CONDITION OF THE "EXPERIENCED PAIN". THE UNIT WAS TESTED AND THE UNIT STOPPED BEEPING WHEN THE DUMMY LOAD WAS ENTERED. REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER AND THE FINDINGS FROM THE INVESTIGATION INDICATED THAT NO PHYSICAL AND/OR DEVICE FUNCTIONAL CONDITION COULD BE FOUND THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT OF "PAIN". NO FAILURE AND/OR FAULT CONDITION COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIT CAUSED THE PATIENT PAIN AND DOUBLED HER BLOOD PRESSURE. THE PATIENT WORE THE UNIT FROM 2 TO 6 HOURS FOR A WEEK. EVERY TIME THE PATIENT PUT ON THE DEVICE IT MADE HER PAIN WORSE AND HER BLOOD PRESSURE GO UP. THE PATIENT CALLED HER DOCTOR AND WAS TOLD SHE DOES NOT HAVE TO USE THE UNIT. THE PATIENT WILL CONDUCT A TIME TEST AND WILL CALL BACK IF ANY ISSUES. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT. IT WAS LATER REPORTED THAT THE PAIN LEVEL WAS AS HIGH AS A 5 OUT OF 10. THE ELECTRODES WERE PLACED AN INCH TO 1.5 INCHES FROM THE INCISION. THE PATIENT WAS MOSTLY CONCERNED HOW HER BLOOD PRESSURE CONTINUED TO ELEVATE WHILE TREATING WITH THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIT CAUSED THE PATIENT PAIN AND DOUBLED HER BLOOD PRESSURE. THE PATIENT WORE THE UNIT FROM 2 TO 6 HOURS FOR A WEEK. EVERY TIME THE PATIENT PUT ON THE DEVICE IT MADE HER PAIN WORSE AND HER BLOOD PRESSURE GO UP. THE PATIENT CALLED HER DOCTOR AND WAS TOLD SHE DOES NOT HAVE TO USE THE UNIT. THE PATIENT WILL CONDUCT A TIME TEST AND WILL CALL BACK IF ANY ISSUES. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806949 BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM SPINALPAK ASSEMBLY LOF EBI, LLC. 1067716 00812301020218

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE H10 NARRATIVE.| SEE H10 NARRATIVE.