BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Mar 17, 2026
Report 0002242816-2026-00028 · MDR key 24616096
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR · Unknown
- Pain
Narrative
Additional Manufacturer Narrative
SECTION B3: THE DATE OF THE EVENT IS UNKNOWN AND IS ESTIMATED TO HAVE OCCURRED IN FEBRUARY OF 2026. 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. FILE.
Description of Event or Problem
THE PATIENT REPORTED THAT SHE EXPERIENCED SEVERE PAIN WHILE TREATING WITH THE UNIT. THE PATIENT WORE THE UNIT ALL THE TIME, AND AFTER A FEW HOURS, SHE WAS IN PAIN. THE PATIENT STATED SHE WORE THE UNIT ON HER BACK, AND SHE HAS METAL IN HER BODY FROM HER SURGERY. THE PATIENT SPOKE TO HER DOCTOR, WHO TOLD HER TO NO LONGER WEAR THE UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS NOT RETURNED.