BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Jun 16, 2026
Report 0002242816-2026-00075 · MDR key 25517564
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHEN USING THE SPINALPAK DEVICE. THE PATIENT WORE THE UNIT FOR 12 TO 14 HOURS AND COULD NOT STAND UP AFTER TREATMENT. THE PATIENT CONTACTED THEIR DOCTOR WHO ADVISED THEM TO PAUSE TREATMENT UNTIL THEIR FOLLOW UP APPOINTMENT. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
SECTION B3: AS DATE OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS MAY OF 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. THE DEVICE IS USED FOR TREATMENT.