BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS (B)(6) OF 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.

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT AFTER SHE SPOKE WITH PAG ABOUT HER BILL. THE PATIENT CLAIMS SHE COULD NOT USE THE UNIT. IN (B)(6) SHE USED IT FOR 1 DAY FOR 4 HOURS. THEN APPROXIMATELY 4 HOURS WENT BY BEFORE SHE WENT TO BED. AT NIGHT SHE WAS IN TERRIBLE PAIN THAT FELT LIKE IT WAS IN HER BONES. HER PAIN WAS AN 8 OR 9 OUT OF 10. SHE STOPPED USING THE UNIT. THEN IN NOVEMBER HER PHYSICAL THERAPIST TOLD HER SHE NEEDED TO TRY TO USE THE UNIT. SO IN (B)(6) SHE TRIED THE UNIT FOR APPROXIMATELY 4 HOURS ONE DAY. THEN ABOUT 4 HOURS LATER SHE WENT TO BED AND HER PAIN WAS AN 8 OR 9 OUT OF 10. THE PATIENT DIDN'T USE THE UNIT AGAIN BECAUSE OF THE INCIDENT. THEN IN APPROXIMATELY (B)(6) AT A FOLLOW UP VISIT THE PATIENT SPOKE WITH DR (B)(6) AND HE SAID IF SHE FELT LIKE SHE COULDN'T USE THE UNIT IT WAS OK TO DISCONTINUE. THE PATIENT CALLED PAG ON (B)(6) 26 BECAUSE OF A BILL SHE RECEIVED AND SHE WANTED TO RETURN THE UNIT. A LABEL WAS SHIPPED FOR UNIT RETURN.