BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

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 APPEARS TO BE IN GOOD CONDITION VISUALLY. THE COMPLIANCE DATA FOR THE SPINAL PAK STIMULATOR WAS DOWNLOADED ON OCTOBER 7, 2025. THE COMPLIANCE DATA INDICATES THE UNIT WAS TREATED FOR 0 DAYS, 8 HOURS, AND 0 MINUTES. REVIEW OF THE DHR INDICATES THAT UNIT WAS MANUFACTURED ON AUGUST 13, 2025. NO NONCONFORMANCES OR DEVIATIONS WERE REPORTED ON THE DHR. THE SP UNIT RAN A BURN-IN STAND-ALONE ¿BATTERY¿ FOR MORE THAN 24 HOURS WITH NO PROBLEMS. REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER AND THE FINDINGS FROM THE INVESTIGATION INDICATED THAT NO PHYSICAL OR DEVICE FUNCTIONAL CONDITION COULD BE FOUND, AND THAT COULD NOT BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT OF "PAIN". NO FAILURE OR FAULT CONDITIONS WERE FOUND OR CONFIRMED. THEREFORE, NO FURTHER ACTION IS REQUIRED AT THIS TIME. REVIEW OF COMPLAINT HISTORY IDENTIFIED (45) TOTAL COMPLAINTS FROM (AUGUST 13, 2024) TO (AUGUST 13, 2025) FOR PN(1067716, 1067717) 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 SHE WAS IN SO MUCH PAIN THE FIRST 2 WEEKS OF USING THE UNIT. STATED WHEN SHE STOP USING THE UNIT, PAIN DID NOT GO AWAY UNTIL THE NEXT DAY. SHE TALK WITH HER DOCTOR AND HE TOLD HER TO TRY USING THE UNIT AGAIN. SHE TRIED IT AND PAIN CAME BACK. THE DOCTOR TOLD HER TO STOP AND CALL EBI. SHE STATED THAT THE DOCTOR REALLY WANTS HER TO USE THE UNIT. THE CS ADVISED HER TO WAIT UNTIL SHE RECEIVES REPLACEMENT AND THEN CONDUCT A TIME-TEST. ADVISED HER TO CALL BACK WITH ANY ISSUES DURING THE TIME TEST. THE PATIENT WILL RETURN THE UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS WERE REVIEWED, NO DISCREPANCIES WERE FOUND. 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 SHE WAS IN SO MUCH PAIN THE FIRST 2 WEEKS OF USING THE UNIT. STATED WHEN SHE STOP USING THE UNIT, PAIN DID NOT GO AWAY UNTIL THE NEXT DAY. SHE TALK WITH HER DOCTOR AND HE TOLD HER TO TRY USING THE UNIT AGAIN. SHE TRIED IT AND PAIN CAME BACK. THE DOCTOR TOLD HER TO STOP AND CALL EBI. SHE STATED THAT THE DOCTOR REALLY WANTS HER TO USE THE UNIT. THE CS ADVISED HER TO WAIT UNTIL SHE RECEIVES REPLACEMENT AND THEN CONDUCT A TIME-TEST. ADVISED HER TO CALL BACK WITH ANY ISSUES DURING THE TIME TEST. THE PATIENT WILL RETURN THE UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS RETURNED FOR EVALUATION.