BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received May 6, 2026
Report 0002242816-2026-00057 · MDR key 25093523
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHILE TREATING WITH THE SPINALPAK. THE PATIENT WORE THE DEVICE FOR 2 TO 3 HOURS. THE PATIENT RATED THE DISCOMFORT LEVEL AT A 2 OUT OF 10, WITH 10 BEING THE HIGHEST. THEN, AT NIGHT IN BED, THE PATIENT EXPERIENCED WORSE PAIN AT A 7 OR 8 OUT OF 10. THE PATIENT CONTINUED TREATMENT WITH THIS DISCOMFORT FOR ABOUT ONE WEEK. THEN THE PATIENT TOOK A BREAK FROM TREATMENT AND THE PAIN SUBSIDED. AT THIS POINT THE PATIENT CHOSE TO DISCONTINUE TREATMENT. THE PATIENT DID NOT DISCUSS THE PAIN WITH THEIR DOCTOR. THE PATIENT HAD NOT INCREASED THEIR ACTIVITY LEVEL. THE PATIENT REPORTED THE PAIN WAS BENEATH THE SURFACE OF THE SKIN AND FELT LIKE IT WAS IN THEIR BONES. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
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. THE DEVICE IS USED FOR TREATMENT. EBI WILL CONTINUE TO MONITOR FOR TRENDS.