BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION - B4: DATE OF THIS REPORT, D8: DEVICE AVAILABLE FOR EVALUATION, D9: RETURNED TO MANUFACTURER DATE. G3: DATE RECEIVED BY MANUFACTURER. A VISUAL INSPECTION OF THE CUSTOMER RETURNED PRODUCT WAS PERFORMED. INCLUDED WAS ONE SPINALPAK STIMULATOR PART NO. 1067716 WITH SERIAL NO. (B)(6) RECEIVED IN A SHIPPING MAILER CUSHION ENVELOPE. THE RECEIVED PRODUCT LOOKS TO BE IN GOOD CONDITION FROM THE VISUAL/COSMETIC POINT OF VIEW. THE SPINALPAK STIMULATOR WAS RECEIVED FOR EVALUATION. THE DHR WAS REVIEWED IN THE PRODUCT INFORMATION SECTION. ALL EVALUATION RESULTS ARE INCLUDED IN THE PRODUCT EVALUATION SECTION. THE FAILURE WAS NOT CONFIRMED FOR THE REPORTED CONDITION OF "SPAK CAUSED PAIN". THE CONTROLLER WAS TESTED AND OPERATES AS INTENDED. REVIEW OF COMPLAINT HISTORY IDENTIFIED (46) TOTAL COMPLAINTS FROM (AUG 4, 2024) TO (AUG 4, 2025) FOR PN (1067716, (B)(6)) 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. 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 THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT OF "PAIN". NO FAILURE AND/OR FAULT CONDITION COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. NO PHYSICAL AND/OR FUNCTIONAL CONDITION COULD BE FOUND AFTER REVIEW OF THE CERTIFICATE OF CONFORMANCE THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT. THE REPORTED CLAIM COULD BE ASSOCIATED WITH A SIDE EFFECT/CLINICAL CONDITION OF THE PATIENT WHICH IS UNKNOWN. THE REPORTED CONDITION IS RELATED TO CLINICAL FACTORS BEYOND THE SCOPE OF THE DEVICE INVESTIGATION COVERED IN THE COMPLAINT INVESTIGATION AS PART OF THE MANUFACTURING REVIEW. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. EBI WILL CONTINUE TO MONITOR FOR TRENDS. THIS DEVICE IS 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 BY THE SALES REPRESENTATIVE THAT WHILE USING SPINALPAK ASSEMBLY, THE PATIENT EXPERIENCED A LOT OF PAIN. LATER CS CALLED THE PATIENT, THE PATIENT INDICATED THAT THEY ARE USING THE UNIT ON LUMBAR AREA. THE PAIN STARTED AFTER TREATING FOR 8-9 HOURS. THE PATIENT WORE THE UNIT FOR ABOUT 24 HRS. AT THAT TIME, SHE COULD BARELY WALK. THE PAIN WAS ON THE LOWER BACK TOWARDS THE HIP. THE LEGS WERE SO WEAK. THE PATIENT HAD TO USE A WALK TO STAND UP AND MOVE AROUND. THE PAIN LEVEL WAS 6, THE ACHINESS WAS BAD. THE PATIENT WAS NOT USING THE WALKER AT ALL BEFORE. THE PATIENT DID NOT USE THE UNIT AND STATED THAT SHE FELT MUCH BETTER AND FELT STRENGTH. THE PATIENT CONTACTED THE DOCTOR; HOWEVER, THE DOCTOR WAS NOT IN THE OFFICE. THE PATIENT TOOK VALIUM AND NORCO. LATER, THE PATIENT INDICATED THAT THEY DID NOT SPEAK WITH THE DOCTOR REGARDING THE PAIN BUT INDICATED THAT SHE WONT BE ABLE TO USE THE UNIT FOR SEVERAL WEEKS DUE TO HOSPITALIZATION RELATED TO BLOOD INFECTION WHICH WAS NOT DUE TO SPINALPAK ASSEMBLY. THE PATIENT INDICATED THAT THE PAIN GOT WORSE WHEN THEY WORE THE UNIT, THE LEVEL WAS 10, IT WAS BAD. THE PATIENT WAS ONLY TREATED FOR 2 DAYS. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS NOT RETURNED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION - H6: METHOD, RESULTS, CONCLUSIONS THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS NOT RETURNED TO HIGHRIDGE MEDICAL FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT WHILE USING SPINALPAK ASSEMBLY, THE PATIENT EXPERIENCED A LOT OF PAIN. LATER CS CALLED THE PATIENT, THE PATIENT INDICATED THAT THEY ARE USING THE UNIT ON LUMBAR AREA. THE PAIN STARTED AFTER TREATING FOR 8-9HOURS. THE PATIENT WORE THE UNIT FOR ABOUT 24 HRS. AT THAT TIME, SHE COULD BARELY WALK. THE PAIN WAS ON THE LOWER BACK TOWARDS THE HIP. THE LEGS WERE SO WEAK. THE PATIENT HAD TO USE A WALK TO STAND UP AND MOVE AROUND. THE PAIN LEVEL WAS 6, THE ACHINESS WAS BAD. THE PATIENT WAS NOT USING THE WALKER AT ALL BEFORE. THE PATIENT DID NOT USE THE UNIT AND STATED THAT SHE FELT MUCH BETTER AND FELT STRENGTH. THE PATIENT CONTACTED THE DOCTOR; HOWEVER, THE DOCTOR WAS NOT IN THE OFFICE. THE PATIENT TOOK VALIUM AND NORCO. LATER, THE PATIENT INDICATED THAT THEY DID NOT SPEAK WITH THE DOCTOR REGARDING THE PAIN BUT INDICATED THAT SHE WONT BE ABLE TO USE THE UNIT FOR SEVERAL WEEKS DUE TO HOSPITALIZATION RELATED TO BLOOD INFECTION WHICH WAS NOT DUE TO SPINALPAK ASSEMBLY. THE PATIENT INDICATED THAT THE PAIN GOT WORSE WHEN THEY WORE THE UNIT, THE LEVEL WAS 10, IT WAS BAD. THE PATIENT WAS ONLY TREATED FOR 2 DAYS. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS NOT RETURNED.

Additional Manufacturer Narrative

B3: ESTIMATED DATE OF THE EVENT IS AUGUST 2025. 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 SALES REPRESENTATIVE THAT WHILE USING SPINALPAK ASSEMBLY, THE PATIENT EXPERIENCED A LOT OF PAIN. LATER CS CALLED THE PATIENT, THE PATIENT INDICATED THAT THEY ARE USING THE UNIT ON LUMBAR AREA. THE PAIN STARTED AFTER TREATING FOR 8-9HOURS. THE PATIENT WORE THE UNIT FOR ABOUT 24 HRS. AT THAT TIME, SHE COULD BARELY WALK. THE PAIN WAS ON THE LOWER BACK TOWARDS THE HIP. THE LEGS WERE SO WEAK. THE PATIENT HAD TO USE A WALK TO STAND UP AND MOVE AROUND. THE PAIN LEVEL WAS 6, THE ACHINESS WAS BAD. THE PATIENT WAS NOT USING THE WALKER AT ALL BEFORE. THE PATIENT DID NOT USE THE UNIT AND STATED THAT SHE FELT MUCH BETTER AND FELT STRENGTH. THE PATIENT CONTACTED THE DOCTOR, HOWEVER THE DOCTOR WAS NOT IN THE OFFICE. THE PATIENT TOOK VALIUM AND NORCO. LATER, THE PATIENT INDICATED THAT THEY DID NOT SPEAK WITH THE DOCTOR REGARDING THE PAIN BUT INDICATED THAT SHE WONT BE ABLE TO USE THE UNIT FOR SEVERAL WEEKS DUE TO HOSPITALIZATION RELATED TO BLOOD INFECTION WHICH WAS NOT DUE TO SPINALPAK ASSEMBLY. THE PATIENT INDICATED THAT THE PAIN GOT WORSE WHEN THEY WORE THE UNIT, THE LEVEL WAS 10, IT WAS BAD. THE PATIENT WAS ONLY TREATED FOR 2 DAYS. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS NOT RETURNED.