BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Jun 5, 2026
Report 0002242816-2026-00071 · MDR key 25414848
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Pain
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
SECTION B3: AS THE DAY 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 VALIDCONCLUSION 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.
Description of Event or Problem
THE SALES REP REPORTED THAT THE PATIENT EXPERIENCED A BURNING PAIN IN HER BUTTOCKS AFTER SLEEPING WITH THE DEVICE LAST WEEKEND. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND THAT THE PADS HAD BURNED HER ON HER BACK. THE PATIENT STATED SHE HAD PAIN IN HER BUTTOCKS. THE 72R ELECTRODES WERE CLOSE TO EACH OTHER, 3 INCHES APART. THE PATIENT STATED SHE HAS 2 RED MARKS ON HER BACK. SHE HAD THE ELECTRODES ON FOR 2 OR 3 DAYS WHEN SHE GOT THE BURN ON (B)(6). THE PATIENT STATED SHE HAS PAIN ON HER BUTTOCKS. THE PATIENT WENT TO HER PCP TODAY AND GOT AN INJECTION FOR THE PAIN. THE PATIENT STATED THE PAIN HAS GONE AWAY. THE PATIENT DID NOT CALL THE SURGEON. THE PATIENT HAS INCREASED HER DAILY ACTIVITIES. HER FOOT STARTED SWELLING. THE PAIN LEVEL FROM THE BURN WAS A 10. THE PATIENT ASKED HER HUSBAND TO TAKE THE ELECTRODES OFF. THE PAIN IN THE BUTTOCKS WAS A 10 AS WELL. THE PATIENT STATED THAT SHE DID NOT HAVE THIS PAIN BEFORE. THE PATIENT CANNOT SLEEP BECAUSE OF THE PAIN. THE PATIENT DOES NOT WANT TO CONTINUE TREATMENT. NO FURTHER CONSEQUENCES WERE REPORTED.