BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM/BIOMET

    MDR report key: 23031874 · Received September 11, 2025

    Report

    Report Number
    0002242816-2025-00115
    Event Type
    Injury
    Date Received
    September 11, 2025
    Report Date
    January 16, 2026
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    UDI-DI
    00812301020218
    PMA / PMN Number
    P850022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN B4: DATE OF THE REPORT. ADDITIONAL INFORMATION IN H4: MANUFACTURE DATE, G3, H6 AND H10: ADDITIONAL NARRATIVE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE SPINALPAK CONTROLLER WAS NOT RETURNED TO EBI FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR TRENDS.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO HIGHRIDGE MEDICAL FOR EVALUATION; THEREFORE, NO PRODUCT EVALUATION HAS BEEN CONDUCTED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILES ACCORDINGLY. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR TRENDS.

    Description of Event or Problem · 0

    THE PATIENT STATED THAT HE HAD SERVER PAIN WHILE USING UNIT. PAIN STARTED FIRST 3 DAYS, HE SPOKE WITH HIS DOCTOR AND WAS TOLD TO STOP WEARING UNIT. PATIENT RECEIVED UNIT (B)(6) 2025 PATIENT WOULD LIKE TO RETURN UNIT. PATIENT ALSO MENTIONED, HE RECEIVED BILL AND HE AS TOLD HE WOULD NOT BE BILL FOR UNIT. EMAIL PAG TO CONTACT PATIENT. EMAIL CAROL W TO SEE IF UNIT NEEDS TO BE RETURNED. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT. NO FURTHER CONSEQUENCES ARE REPORTED. THE SPINALPAK CONTROLLER WAS NOT RETURNED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    THE PATIENT STATED THAT HE HAD SERVER PAIN WHILE USING UNIT. PAIN STARTED FIRST 3 DAYS, HE SPOKE WITH HIS DOCTOR AND WAS TOLD TO STOP WEARING UNIT. PATIENT RECEIVED UNIT (B)(6) 2025. PATIENT WOULD LIKE TO RETURN UNIT. PATIENT ALSO MENTIONED, HE RECEIVED BILL AND HE WAS TOLD HE WOULD NOT BE BILL FOR UNIT. EMAIL (B)(6) TO CONTACT PATIENT. EMAIL (B)(6) TO SEE IF UNIT NEEDS TO BE RETURNED. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2705688 BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM/BIOMET STIMULATOR, BONE GROWTH, NON-INVASIVE LOF EBI, LLC. 1067716 00812301020218

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other