BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

WITH A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED AS OF 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 THAT THE PATIENT WAS NOT ABLE TO USE THE DEVICE. THE PATIENT HAD SEVERE BRUISING AFTER HIS SURGERY. THE PATIENT ADVISES HIS DOCTOR OF THE MATTER. THE PATIENT WAS NOT ABLE TO USE THE UNIT MORE THAN 2 HOURS AT A TIME. THE PATIENT STATED THAT AFTER 2 HOURS OF TREATMENT IT WAS PAINFUL, AND HE STOPPED USING THE UNIT. DOCTOR WAS AWARE OF THIS. THE PATIENT HAS BEEN ON MEDICATION EVER SINCE HIS SURGERY. THE PAIN LEVEL WAS RATED A 10 OUT OF 10 BEFORE USING THE STIMULATOR.

Additional Manufacturer Narrative

CORRECTED DATA IN THE FOLLOWING FIELDS - G1: CONTACT OFFICE NAME AND EMAIL ADDRESS, G3: PMA/510K, ADDITIONAL INFORMATION IN FOLLOWING FIELDS- B4: DATE OF THIS REPORT, 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 (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 JUNE 2, 2025, THE COMPLIANCE DATA INDICATES THE UNIT TREATED FOR 9 DAYS 16 HOURS AND 55 MINUTES. REVIEW OF THE DHR INDICATES THAT UNIT WAS MANUFACTURED ON OCTOBER 6, 2023. 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, BURNING SENSATION". NO FAILURE AND/OR FAULT CONDITIONS COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED CURRENTLY. REVIEW OF COMPLAINT HISTORY IDENTIFIED (27) TOTAL COMPLAINTS FROM (MAY 13, 2024) TO (MAY 13, 2025) FOR PN (1067716, 1067717) AND EVENTS RELATED TO (PAIN). KEYWORD SEARCH CRITERIA:(COMPLAINT CODE: MEDICAL: PAIN) 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.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO USE THE DEVICE. THE PATIENT HAD SEVERE BRUISING AFTER HIS SURGERY. THE PATIENT ADVISES HIS DOCTOR OF THE MATTER. THE PATIENT WAS NOT ABLE TO USE THE UNIT MORE THAN 2 HOURS AT A TIME. THE PATIENT STATED THAT AFTER 2 HOURS OF TREATMENT IT WAS PAINFUL, AND HE STOPPED USING THE UNIT. DOCTOR WAS AWARE OF THIS. THE PATIENT HAS BEEN ON MEDICATION EVER SINCE HIS SURGERY. THE PAIN LEVEL WAS RATED A 10 OUT OF 10 BEFORE USING THE STIMULATOR. NO FURTHER CONSEQUENCES ARE REPORTED. THE SPINALPAK WAS RECEIVED FOR FURTHER EVALUATION.