BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT THAT THE UNIT CAUSED PAIN. THE PATIENT WORE UNIT 24-7 IN BEGINNING. THE PATIENT CONTACTED THEIR DOCTOR AND WERE ADVISED TO CUT BACK ON TREATMENT TIME. THE PATIENT ONLY TREATED AT NIGHT FOR 8-10 HOURS, HOWEVER, WAS STILL EXPERIENCING PAIN. LATER, DUE TO CONTINUOUS PAIN, DOCTOR ADVISED TO STOP WEARING THE UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS RECEIVED FOR FURTHER 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 JULY 2025. CORRECTED DATA IN FOLLOWING FIELDS, G1: CONTACT OFFICE NAME AND EMAIL ADDRESS ADDITIONAL INFORMATION IN FOLLOWING FIELDS- B4: DATE OF THIS REPORT, B5: ADDITIONAL NARRATIVE, D8, D9, G1, G3: DATE RECEIVED BY MANUFACTURER, 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 NOVEMBER 21, 2025. THE COMPLIANCE DATA INDICATES THE UNIT TREATED FOR 32 DAYS, 12 HOURS AND 28 MINUTES. REVIEW OF THE DHR INDICATES THAT UNIT WAS MANUFACTURED ON MARCH 18, 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 (22) TOTAL COMPLAINTS FROM (JULY 15, 2024) TO (JULY 15, 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.

Additional Manufacturer Narrative

WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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 THE UNIT CAUSED PAIN. THE PATIENT WORE UNIT 24-7 IN BEGINNING. THE PATIENT CONTACTED THEIR DOCTOR AND WERE ADVISED TO CUT BACK ON TREATMENT TIME. THE PATIENT ONLY TREATED AT NIGHT FOR 8-10 HOURS HOWEVER, WAS STILL EXPERIENCING PAIN. LATER, DUE TO CONTINUOUS PAIN, DOCTOR ADVISED TO STOP WEARING THE UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS NOT RETURNED FOR EVALUATION.