BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM/BIOMET

    MDR report key: 23372783 · Received October 23, 2025

    Report

    Report Number
    0002242816-2025-00131
    Event Type
    Injury
    Date Received
    October 23, 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
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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.

    Description of Event or Problem · 0

    THE PATIENT ADVISED THAT EVERY TIME SHE USES THE SPAK, SHE GETS A MIGRAINE. THE PATIENT ADVISED THAT SHE WEARS IT LONGER THAN AN HOUR, THE LONGER IT TAKES FOR THE HEADACHE TO GO AWAY. THE PAIN LEVEL IS A SEVEN OR EIGHT. THE MIGRAINES ARE PRETTY BAD. SHE SPOKE WITH HER PHYSICIAN BUT WASN'T PRESCRIBED ANYTHING, THE PHYSICIAN DID TELL THE PATIENT TO STOP USING THE UNIT. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT. THE PATIENT WOULD LIKE TO RETURN THE UNIT.

    Description of Event or Problem · 0

    THE PATIENT ADVISED THAT EVERY TIME SHE USES THE SPAK, SHE GETS A MIGRAINE. THE PATIENT ADVISED THAT SHE WEARS IT LONGER THAN AN HOUR, THE LONGER IT TAKES FOR THE HEADACHE TO GO AWAY. THE PAIN LEVEL IS A SEVEN OR EIGHT. THE MIGRAINES ARE PRETTY BAD. SHE SPOKE WITH HER PHYSICIAN BUT WASN'T PRESCRIBED ANYTHING, THE PHYSICIAN DID TELL THE PATIENT TO STOP USING THE UNIT. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT. THE PATIENT WOULD LIKE TO RETURN THE UNIT. NO FURTHER CONSEQUENCES ARE REPORTED. THE SPINALPAK CONTROLLER WAS NOT RETURNED FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730027 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 Female Other SEE H10 NARRATIVE.