BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM

Additional Manufacturer Narrative

SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS OCTOBER OF 2025. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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 EXPERIENCING PAIN DURING TREATMENT WITH THE ORTHOPAK. THE PATIENT WAS SWITCHED TO THE BONE HEALING SYSTEM (BHS). IT WAS LATER REPORTED THAT THE PATIENT TRIED USING THE ORTHOPAK FOR ABOUT A WEEK. NO FURTHER INFORMATION COULD BE PROVIDED REGARDING HOW LONG THE PATIENT WAS ABLE TO TREAT WITH THE DEVICE BEFORE THE PAIN STARTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN DURING TREATMENT WITH THE ORTHOPAK. THE PATIENT WAS SWITCHED TO THE BONE HEALING SYSTEM (BHS). IT WAS LATER REPORTED THAT THE PATIENT ATTEMPTED TO USE THE ORTHOPAK FOR ABOUT A WEEK. NO FURTHER INFORMATION COULD BE PROVIDED REGARDING HOW LONG THE PATIENT WAS ABLE TO TREAT WITH THE DEVICE BEFORE THE PAIN STARTED. NO FURTHER CONSEQUENCES ARE REPORTED. THE ORTHOPAK WAS RECEIVED FOR FURTHER EVALUATION.

Additional Manufacturer Narrative

CORRECTED DATA IN THE FOLLOWING FIELDS - G1: CONTACT OFFICE NAME, AND EMAIL ADDRESS. ADDITIONAL INFORMATION IN THE FOLLOWING FIELDS- B4: DATE OF THIS REPORT, B5: ADDITIONAL NARRATIVE, D8, D9, G3: DATE RECEIVED BY MANUFACTURER, H2, H3, H6: EVALUATION CODES. THE ORTHOPAK ASSEMBLY WAS RECEIVED FOR EVALUATION, BUT DUE TO THE NATURE OF THE COMPLAINT AND THE INFORMATION PROVIDED WITHIN THE COMPLAINT FILE, ONLY THE ORTHOPAK STIMULATOR WAS EVALUATED. A VISUAL INSPECTION OF THE CUSTOMER¿S RETURNED PRODUCT WAS PERFORMED. INCLUDED WAS ONE ORTHOPAK STIMULATOR, PART NO. 1067718, WITH SERIAL NUMBER (B)(6), RECEIVED IN A SHIPPING BOX. THE PART RECEIVED APPEARS TO BE IN GOOD CONDITION FROM A VISUAL/COSMETIC STANDPOINT. THE COMPLIANCE DATA FOR THE ORTHOPAK STIMULATOR WAS DOWNLOADED ON MARCH 17, 2026. THE COMPLIANCE DATA INDICATES THE UNIT WAS TREATED FOR 0 DAYS, 1 HOUR, AND 16 MINUTES. THE DHR REVIEW INDICATES THAT THE UNIT WAS MANUFACTURED ON JULY 19, 2025. THERE WERE NO NON-CONFORMANCES OR DEVIATIONS REPORTED ON THE DHR. THE OP UNIT RAN A BURN-IN STAND-ALONE ¿BATTERY¿ FOR MORE THAN 24 HOURS WITHOUT ISSUE. 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 ACTION IS REQUIRED AT THIS TIME. REVIEW OF COMPLAINT HISTORY IDENTIFIED (02) TOTAL COMPLAINTS FROM (B)(6) 2024) TO (B)(6), 2025) FOR PN (B)(4) 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. 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.