BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Feb 9, 2026
Report 0002242816-2026-00012 · MDR key 24293973
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
60 YR · Unknown
- Pain
Narrative
Additional Manufacturer Narrative
SECTION B3: THE DATE OF THE EVENT IS UNKNOWN AND IS ESTIMATED TO HAVE OCCURRED IN JANUARY 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.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT THE DEVICE IS CAUSING HER PAIN. THE PATIENT STATES THAT IT STARTED ABOUT TWO WEEKS AFTER USING THE UNIT. THE PATIENT REPORTED THAT SHE HAD DISCONTINUED WEARING THE UNIT. THE PAIN LEVEL IS A 9. THE PATIENT IS TAKING PERCOCET FOR THE PAIN. THE PATIENT CALLED HER DOCTOR AND IS AWAITING A RETURN CALL. THE PATIENT WILL CALL BACK WITH AN UPDATE. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK WAS NOT RETURNED.