BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Jul 13, 2026
Report 0002242816-2026-00086 · MDR key 25802180
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Pain
- Balance Problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
THE PATIENT REPORTED THAT SHE LOST HER BALANCE AND HIT THE REFRIGERATOR. THE PATIENT STATED THAT THIS IS WHEN SHE STARTED USING THE DEVICE FOR THE PAIN. SHE REPORTED USING THE DEVICE ON THURSDAY AND HAS CONTINUED TO EXPERIENCE PAIN SINCE THE FALL. THE PATIENT RATED HER PAIN AS HIGH AS 8 OUT OF 10 AT ITS WORST AND 5 OR 6 OUT OF 10 AT THE TIME OF THE CALL. THE PATIENT ALSO REPORTED INCREASING HER DAILY ACTIVITY OVER THE WEEKEND. THE PATIENT ASKED WHETHER SHE SHOULD CONTINUE USING THE STIMULATOR. SHE WAS ADVISED THAT THE DEVICE IS INTENDED TO PROMOTE BONE FUSION AND IS NOT INDICATED FOR PAIN RELIEF. THE PATIENT REPORTED THAT EACH TIME SHE HAS USED THE DEVICE, SHE HAS EXPERIENCED PAIN AND DESCRIBED THE SENSATION AS FEELING LIKE AN ELECTRICAL SHOCK. THE PATIENT CONFIRMED THAT SHE DOES NOT HAVE A PACEMAKER OR IMPLANTABLE DEFIBRILLATOR. NO FURTHER CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS JUNE OF 2026. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION CAN 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.