BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Apr 7, 2026
Report 0002242816-2026-00046 · MDR key 24799771
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
61 YR · Male
- Pain
Narrative
Description of Event or Problem
UPDATE (B)(6) 2026: CUSTOMER SERVICE RECEIVED A CALL FROM THE PATIENT WHO STATED HE IS HAVING PAIN. THE PATIENT IS HAVING A SPIKE. IT FEELS LIKE SOMEONE IS PUTTING A NEEDLE ON THE LEFT SIDE OF HIS BACK. THE PATIENT ALSO HAS NERVE ISSUES. THIS STARTED SHORTLY AFTER HE STARTED USING THE SPINALPAK. THE PATIENT CALLED THE SALES REP, (B)(6). THE PATIENT ALSO CONTACTED HIS DOCTOR AND WAS ADVISED NOT TO USE THE UNIT. THE PAIN LEVEL WAS ABOUT AN 8 OR HIGHER. WHEN THE PATIENT IS NOT USING THE STIMULATOR THE PAIN LEVEL IS BETWEEN A 3 AND A 4. NO NEW PRODUCT WAS SHIPPED, NO RETURN NOTED. UPDATE (B)(6) 2026: SALES REP (B)(6) CALLED AND ADVISED THAT THE PATIENT IS EXPERIENCING A TINGLING PAIN WHILE USING THE UNIT. THE PAIN IS FROM THE BUTTOCKS DOWN THE LEG. WHEN HE IS NOT USING THE UNIT, THE PAIN GOES AWAY. THE REP NOTED THAT THE PATIENT WAS APPREHENSIVE ABOUT THE UNIT AT THE TIME OF THE FITTING. THE PATIENT DID CONTACT THE DOCTOR. THE PATIENT HAD A SURGERY ABOUT 7 YEARS AGO WHEN THE SPF WAS IMPLANTED. THE BATTERY WAS REMOVED A COUPLE OF YEARS AGO; THE LEADS ARE STILL IN HIS BODY. PER (B)(6), THERE IS NO CONTRAINDICATION BETWEEN THE SPF AND THE SPINALPAK. THE PATIENT WAS CALLED REGARDING THE PAIN. CUSTOMER SERVICE LEFT A VOICEMAIL REQUESTING A CALL BACK. CUSTOMER SERVICE RECEIVED A CALL FROM THE PATIENT WHO STATED THAT HE WAS HAVING ISSUES WITH HIS UNIT. CUSTOMER SERVICE OFFERED TO TROUBLESHOOT THE UNIT BUT THE PATIENT DECLINED. HE STATED THAT HE WAS WAITING TO TALK TO THE SALES REPRESENTATIVE. NO NEW PRODUCT WAS SHIPPED. NO RETURN NOTED.
Additional Manufacturer Narrative
SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS (B)(6) 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.