BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

THE DEVICE HAS BEEN RETURNED TO HIGHRIDGE MEDICAL FOR EVALUATION HOWEVER, THE EVALUATION HAS NOT BEGUN YET. 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.

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED A MAJOR HEADACHE AND SWOLLEN HANDS WHILE USING THE SPINALPAK DEVICE. THE PATIENT SAW HER DOCTOR WHO ADVISED HER TO STOP USING THE UNIT. THE DOCTOR DID NOT PRESCRIBE ANY MEDICATION. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

SECTION B3: AS THE DAY AND THE MONTH OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED TO HAVE OCCURRED IN 2025. CORRECTED DATA IN FOLLOWING FIELDS - G1: CONTACT OFFICE NAME AND EMAIL ADDRESS ADDITIONAL INFORMATION IN FOLLOWING FIELDS- B4: DATE OF THIS REPORT, D3, H6: EVALUATION CODES. THE SPINAL PAK ASSEMBLY WAS RECEIVED FOR EVALUATION, BUT DUE TO THE NATURE OF THE COMPLAINT AND THE INFORMATION PROVIDED WITHIN THE COMPLAINT FILE, ONLY THE SPINAL PAK STIMULATOR WAS EVALUATED. A VISUAL INSPECTION OF THE CUSTOMER¿S RETURNED PRODUCT WAS PERFORMED. INCLUDED WAS ONE SPINAL PAK STIMULATOR, PART NO. 1067717, WITH SERIAL NUMBER (B)(6), RECEIVED IN A SHIPPING BOX. THE PART RECEIVED LOOKS TO BE IN GOOD CONDITION FROM THE VISUAL/COSMETIC POINT OF VIEW. THE COMPLIANCE DATA FOR THE SPINAL PAK STIMULATOR WAS DOWNLOADED ON SEPTEMBER 18, 2025. THE COMPLIANCE DATA INDICATES THE UNIT WAS TREATED FOR 2 DAYS, 5 HOURS, AND 13 MINUTES. REVIEW OF THE DHR INDICATES THAT UNIT WAS MANUFACTURED ON JUNE 11, 2025. THERE WERE NO NON-CONFORMANCES OR DEVIATIONS REPORTED ON THE DHR. THE SP UNIT RAN BURN-IN STAND-ALONE ¿BATTERY¿ ONLY FOR MORE THAN 24 HOURS WITH NO PROBLEM. REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER AND THE FINDINGS FROM THE INVESTIGATION INDICATED THAT NO PHYSICAL AND/OR DEVICE FUNCTIONAL CONDITION COULD BE FOUND, AND THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT OF "PAIN". NO FAILURE AND/OR FAULT CONDITIONS COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED CURRENTLY. REVIEW OF COMPLAINT HISTORY IDENTIFIED (45) TOTAL COMPLAINTS FROM (SEPTEMBER 3, 2024) TO (SEPTEMBER 3, 2025) FOR PN (1067716, (B)(6)) AND EVENTS RELATED TO (PAIN). KEYWORD SEARCH CRITERIA: (COMPLAINT CODE: MEDICAL: PAIN) THE SEARCH COULD NOT BE SPECIFIED FURTHER BECAUSE THE MAIN COMPLAINT WAS PAIN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED A MAJOR HEADACHE AND SWOLLEN HANDS WHILE USING THE SPINALPAK DEVICE. THE PATIENT SAW HER DOCTOR WHO ADVISED HER TO STOP USING THE UNIT. THE DOCTOR DID NOT PRESCRIBE ANY MEDICATION. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS RETURNED FOR EVALUATION.