BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Jun 30, 2026
Report 0002242816-2026-00080 · MDR key 25665573
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Pain
Narrative
Additional Manufacturer Narrative
SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS JUNE 2026. 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.
Description of Event or Problem
THE SALES REP REPORTED THAT THE PATIENT IS EXPERIENCING ISSUES WHILE USING THE UNIT. THE PATIENT SPOKE WITH CUSTOMER SERVICE AND STATED THAT SHE SUFFERS FROM A PRE-EXISTING CONDITION, SEVERE RESTLESS LEG SYNDROME. THE PATIENT EXPERIENCED AN EXACERBATION OF THESE SYMPTOMS WHEN SHE STARTED TREATMENT WITH THE UNIT. THE PATIENT STATED IT WAS VERY UNCOMFORTABLE; SHE GOT NO SLEEP AND WAS IN PAIN. THE PAIN LEVEL WAS 4 OUT OF 10. THE PATIENT SPOKE WITH HER SURGEON'S OFFICE, AND THEY SUGGESTED SHE CONSULT WITH HER NEUROLOGIST. THE NEUROLOGIST ADVISED THE PATIENT TO DISCONTINUE THE SPAK TREATMENT AS THE BENEFITS DO NOT OUTWEIGH THE SYMPTOMS SHE IS EXPERIENCING. NO FURTHER CONSEQUENCES WERE REPORTED.