BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT FELT NAUSEOUS WHILE WEARING THE DEVICE. THE PATIENT WAS ADVISED BY THEIR PHYSICIAN TO DISCONTINUE USE OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

SECTION B3: THE EVENT DATE IS ESTIMATED AS APRIL OF 2025 AS THE DAY OF THE EVENT IS UNKNOWN. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT FELT NAUSEOUS WHILE WEARING THE DEVICE. THE PATIENT WAS ADVISED BY THEIR PHYSICIAN TO DISCONTINUE USE OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THE SPINALPAK WAS RECEIVED FOR FURTHER EVALUATION.

Additional Manufacturer Narrative

CORRECTED DATA IN THE FOLLOWING FIELDS - A: PATIENT INFORMATION,G1: CONTACT OFFICE NAME AND EMAIL ADDRESS ADDITIONAL INFORMATION IN FOLLOWING FIELDS- B4: DATE OF THIS REPORT, B5: ADDITIONAL NARRATIVE, D8, D9, G3: DATE RECEIVED BY MANUFACTURER, H2, H3, 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 M84562 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 JUNE 2, 2025. THE COMPLIANCE DATA INDICATES THE UNIT TREATED FOR 1 DAY 17 HOURS AND 43 MINUTES. REVIEW OF THE DHR INDICATES THAT UNIT WAS MANUFACTURED ON APRIL 4, 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 "NAUSEOUS". NO FAILURE AND/OR FAULT CONDITIONS COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED CURRENTLY. REVIEW OF COMPLAINT HISTORY IDENTIFIED (28) TOTAL COMPLAINTS FROM (APR 24, 2024) TO (APRIL 24, 2025) FOR PN (1067716, 1067717) AND EVENTS RELATED TO (MEDICAL: OTHER). KEYWORD SEARCH CRITERIA: (NAUSEA) THE SEARCH WAS SPECIFIED TO THE KEYWORD "NAUSEA" IN THE COMPLAINT DESCRIPTION. THE SEARCH IDENTIFIED 2 COMPLAINTS. DEVICE USAGE: THIS DEVICE WAS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.