BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

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. SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS APRIL OF 2025.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN HIS RIGHT HAND. THE PAIN WAS IN THE KNUCKLES, MAINLY IN THE RIGHT INDEX FINGER. THE PAIN LEVEL WAS 8 OUT OF 10 WITH 10 BEING THE WORST. PATIENT STATED IT FELT LIKE SOMEBODY BROKE HIS FINGER. THE PATIENT STATED THAT HE BROKE HIS RIGHT WRIST 40 YEARS AGO. THE PATIENT STARTED TREATMENT ON (B)(6) 2025 AND TREATS FOR 22-23 HOURS PER DAY. THE PATIENT ALSO EXPERIENCED PAIN IN BOTH HIPS AND RATED THE PAIN AT A 6 OR 7 OUT OF 10. PATIENT DESCRIBED IT AS A PULSATING PAIN. THE PATIENT NOTED THAT HE HAS ARTHRITIS IN HIS HIP AND HAS HAD TROUBLE WALKING AND KEEPING BALANCE FOR THE PAST COUPLE OF YEARS. THE PATIENT STOPPED TREATMENT FOR 2 DAYS AND STATED THAT HIS BODY RETURNED TO NORMAL. THE PATIENT WANTS TO CONTINUE TREATMENT. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IN B4, B5, G3, H6 AND H10: ADDITIONAL NARRATIVE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN HIS RIGHT HAND. THE PAIN WAS IN THE KNUCKLES, MAINLY IN THE RIGHT INDEX FINGER. THE PAIN LEVEL WAS 8 OUT OF 10 WITH 10 BEING THE WORST. PATIENT STATED IT FELT LIKE SOMEBODY BROKE HIS FINGER. THE PATIENT STATED THAT HE BROKE HIS RIGHT WRIST 40 YEARS AGO. THE PATIENT STARTED TREATMENT ON (B)(6) 2025 AND TREATS FOR 22-23 HOURS PER DAY. THE PATIENT ALSO EXPERIENCED PAIN IN BOTH HIPS AND RATED THE PAIN AT A 6 OR 7 OUT OF 10. PATIENT DESCRIBED IT AS A PULSATING PAIN. THE PATIENT NOTED THAT HE HAS ARTHRITIS IN HIS HIP AND HAS HAD TROUBLE WALKING AND KEEPING BALANCE FOR THE PAST COUPLE OF YEARS. THE PATIENT STOPPED TREATMENT FOR 2 DAYS AND STATED THAT HIS BODY RETURNED TO NORMAL. THE PATIENT WANTS TO CONTINUE TREATMENT. LATER, THE PATIENT STATED THAT HE WAS HAVING AN UNCOMFORTABLE FEELING WHERE THE CONTROLLER WAS PLACED ON HIS RIGHT HIP-WAIST. THE PATIENT THEN STARTED USING THE UNIT WHILE HE WAS SLEEPING FOR ABOUT 2 WEEKS. THE UNCOMFORTABLE FEELING WENT AWAY. THE PATIENT HAS RIGHT HIP ARTHRITIS. THE PATIENT STATED THAT HIS RIGHT HIP ARTHRITIS WAS NOT BOTHERING HIM PRIOR TO USING THE STIMULATOR. THE PATIENT SPOKE TO HIS DOCTOR REGARDING THIS SENSATION. PAIN LEVEL WAS BETWEEN 2 TO 4. THE PATIENT STARTED USING THE CONTROLLER ON THE LEFT SIDE/HIP AND IMMEDIATELY HE STARTED HAVING A PAIN SENSATION. THE PATIENT IS GOING TO HAVE HIP SURGERY IN THE NEAR FUTURE. THE DOCTOR DID NOT PRESCRIBE ANYTHING FOR THE PAIN. THE PATIENT IS NOW USING THE UNIT AT NIGHT. THE PATIENT DOES NOT WANT TO HAVE THE CONTROLLER NEAR HIS BODY. LATER, IT WAS REPORTED BY THE PATIENT THAT HE HAS BEEN HAVING CONTINUED ISSUE WITH HIS STIMULATOR. PATIENT SAID THAT WHEN HE WEARS THE STIMULATOR HE FEELS "ILL" AND WHEN HE DISCONTINUES US THAT "ILL FEELING" GOES AWAY. CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT WHO STATED THAT HE WORE THE UNIT 24 HOURS TO 4 HOURS TO 2 HOURS TO A FEW MINUTES. FELT IT WAS CAUSING A HEADACHE. BUT THE PATIENT WAS NOT SURE IF IT WAS THE UNIT DUE TO ALL OF THE HEALTH ISSUES OR MEDICATIONS HE'S HAVING. PATIENT STATED HE HAS STOPPED WEARING THE UNIT. THE PATIENT INDICATED THAT THE UNIT WAS WORKING AS INDICATED AND NO ISSUES WITH ITS FUNCTION. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IN B2, B5, B7, H4: MANUFACTURE DATE, H6 AND H10: ADDITIONAL NARRATIVE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE SPINALPAK ASSEMBLY WAS NOT RETURNED TO HIGHRIDGE MEDICAL FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN HIS RIGHT HAND. THE PAIN WAS IN THE KNUCKLES, MAINLY IN THE RIGHT INDEX FINGER. THE PAIN LEVEL WAS 8 OUT OF 10 WITH 10 BEING THE WORST. PATIENT STATED IT FELT LIKE SOMEBODY BROKE HIS FINGER. THE PATIENT STATED THAT HE BROKE HIS RIGHT WRIST 40 YEARS AGO. THE PATIENT STARTED TREATMENT ON (B)(6) 2025 AND TREATS FOR 22-23 HOURS PER DAY. THE PATIENT ALSO EXPERIENCED PAIN IN BOTH HIPS AND RATED THE PAIN AT A 6 OR 7 OUT OF 10. PATIENT DESCRIBED IT AS A PULSATING PAIN. THE PATIENT NOTED THAT HE HAS ARTHRITIS IN HIS HIP AND HAS HAD TROUBLE WALKING AND KEEPING BALANCE FOR THE PAST COUPLE OF YEARS. THE PATIENT STOPPED TREATMENT FOR 2 DAYS AND STATED THAT HIS BODY RETURNED TO NORMAL. THE PATIENT WANTS TO CONTINUE TREATMENT. LATER, THE PATIENT STATED THAT HE WAS HAVING AN UNCOMFORTABLE FEELING WHERE THE CONTROLLER WAS PLACED ON HIS RIGHT HIP-WAIST. THE PATIENT THEN STARTED USING THE UNIT WHILE HE WAS SLEEPING FOR ABOUT 2 WEEKS. THE UNCOMFORTABLE FEELING WENT AWAY. THE PATIENT HAS RIGHT HIP ARTHRITIS. THE PATIENT STATED THAT HIS RIGHT HIP ARTHRITIS WAS NOT BOTHERING HIM PRIOR TO USING THE STIMULATOR. THE PATIENT SPOKE TO HIS DOCTOR REGARDING THIS SENSATION. PAIN LEVEL WAS BETWEEN 2 TO 4. THE PATIENT STARTED USING THE CONTROLLER ON THE LEFT SIDE/HIP AND IMMEDIATELY HE STARTED HAVING A PAIN SENSATION. THE PATIENT IS GOING TO HAVE HIP SURGERY IN THE NEAR FUTURE. THE DOCTOR DID NOT PRESCRIBE ANYTHING FOR THE PAIN. THE PATIENT IS NOW USING THE UNIT AT NIGHT. THE PATIENT DOES NOT WANT TO HAVE THE CONTROLLER NEAR HIS BODY. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.