BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Description of Event or Problem

PER CS REP (B)(6), RECEIVED EMAIL FROM SALES REP, (B)(6). SUBJECT: PATIENT COMPLAINT (B)(4). HELLO, I RECEIVED THIS TEXT MESSAGE FROM THIS PATIENT OVER THE WEEKEND AND I CALLED HER BACK ON SATURDAY BUT DID NOT REACH HER AND JUST LEFT A VOICEMAIL. I JUST TRIED HER AGAIN TONIGHT AND SPOKE TO HER AND I TOLD HER THAT SOMEBODY FROM CUSTOMER SERVICE WOULD GIVE HER A CALL, BUT THAT THEY'RE PROBABLY GOING TO TRY AND RECOMMEND SHE START USING IT FOR JUST AN HOUR OR TWO A DAY AND THEN SLOWLY BUILD UP. SHE SAID THAT SHE EXPERIENCED SOME SPASM PAIN IN HER RIGHT HIP ALONG WITH SOME EDEMA. SHE TOOK IT OFF ON SATURDAY AND HASN'T PUT IT ON SINCE AND SHE ALSO HAS LOST SOME STRENGTH IN HER RIGHT LOWER EXTREMITY. IF SOMEBODY FROM CUSTOMER SERVICE, COULD PLEASE CALL HER ON WEDNESDAY TO DISCUSS THAT WOULD BE GREAT. (B)(6) THIS IS (B)(6). THE BONE GROWTH STIMULATOR CAUSED PAIN AND LOSS OF STRENGTH IN MY RIGHT LEG. FINALLY TOOK IT OFF LAST EVENING UNTIL I CAN TALK TO YOU. (B)(6). I CALLED THE PATIENT REGARDING PAIN AND LOSS OF STRENGTH IN THE RIGHT LEG. THE PATIENT STATED THAT THE STIMULATOR CAUSED PAIN ON THE RIGHT HIP AND SWELLING. THE PATIENT TOOK OFF THE UNIT AND SHE STARTED FEELING BETTER. THE PATIENT STATED THAT SHE HAS A DOCTOR'S APPOINTMENT AND TO CALL BACK IN 3 HOURS. THE PATIENT ALSO STATED THAT SHE HAD SWELLING/EDEMA BEFORE BUT IT WAS GOING AWAY WITH MEDICATION. (B)(6).

Additional Manufacturer Narrative

SECTION B3: AS THE DATE OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS APRIL OF 2026. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION CAN 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. EBI WILL CONTINUE TO MONITOR TRENDS.