BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Feb 23, 2026
Report 0002242816-2026-00016 · MDR key 24413812
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Pain
Narrative
Additional Manufacturer Narrative
SECTION B3: THE DATE OF THE EVENT IS UNKNOWN. 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. THE DEVICE IS USED FOR TREATMENT. EBI WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE PAIN AFTER 4 HOURS OF TREATMENT WITH THE DEVICE. THE PATIENT RATED THE PAIN LEVEL A 10 OUT OF 10 AND STATED THAT THE PAIN WAS SIMILAR TO THE PAIN PRIOR TO HER SURGERY. THE PAIN SHOOTS DOWN HER RIGHT SIDE, RIGHT HIP, AND TRAVELS DOWN TO HER TOES AND MAKES HER FOOT TURN IN. THE PAIN OCCURS AT NIGHT WHILE SLEEPING AND NOT TREATING WITH THE DEVICE, BUT IT OCCURS ON THE SAME DAYS AS HER TREATMENTS. THE PATIENT RECENTLY INCREASED PHYSICAL ACTIVITY WITH PHYSICAL THERAPY AS SHE IS COMMITTED TO HER HEALING. IT WAS LATER REPORTED THAT THE PATIENT¿S DOCTOR ADVISED TO DISCONTINUE TREATMENT. THE PAIN ALMOST ENTIRELY WENT AWAY AFTER STOPPING TREATMENT WITH THE SPINALPAK DEVICE. NOTHING WAS PRESCRIBED FOR THE PAIN. NO FURTHER INFORMATION WAS PROVIDED.