BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

CORRECTIONS IN B4: DATE OF THE REPORT, B5: EVENT DESCRIPTION, G6: TYPE OF REPORT, AND H3 ADDITIONAL INFORMATION IN A: AGE, D8-9, G3, H2, H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS AND H10: ADDITIONAL NARRATIVE. INVESTIGATION SUMMARY: 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 (B)(6) 2025, THE COMPLIANCE DATA INDICATES THE UNIT TREATED FOR 1 DAY 14 HOURS AND 34 MINUTES. REVIEW OF THE DHR INDICATES THAT UNIT WAS MANUFACTURED ON (B)(6) 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 (42) TOTAL COMPLAINTS FROM ((B)(6) 2024) TO ((B)(6) 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. 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 EXPERIENCED PAIN ACROSS THE BACK AND DOWN THE ARMS 2 HOURS AFTER COMPLETING TREATMENT FOR THE FIRST TIME. THE PAIN LEVEL WAS RATED AN 8 OUT OF 10, WITH 20 BEING THE WORST. THE PATIENT IS TREATING THE CERVICAL AREA. THE PATIENT NOTED THAT SHE DID INCREASE HER LEVEL OF ACTIVITY BY INCREASING HER DAILY WALK. THE PATIENT HAD TO TAKE A PRESCRIPTION NARCOTIC FOR THE PAIN BUT DID NOT CONTACT HER DOCTOR. THE PATIENT TREATED WITH THE DEVICE FOR 2 HOURS IT WAS LATER REPORTED THAT THE PATIENT DISCUSSED THE PAIN ISSUE WITH HER DOCTOR AND WAS ADVISED TO DISCONTINUE USE. THE PHYSICIAN DID NOT PRESCRIBE OR RECOMMENDED ANYTHING ELSE FOR THE PATIENT. NO FURTHER CONSEQUENCES WERE REPORTED. SPINALPAK ASSEMBLY WAS RETURNED FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN ACROSS THE BACK AND DOWN THE ARMS 2 HOURS AFTER COMPLETING TREATMENT FOR THE FIRST TIME. THE PAIN LEVEL WAS RATED AN 8 OUT OF 10, WITH 20 BEING THE WORST. THE PATIENT IS TREATING THE CERVICAL AREA. THE PATIENT NOTED THAT SHE DID INCREASE HER LEVEL OF ACTIVITY BY INCREASING HER DAILY WALK. THE PATIENT HAD TO TAKE A PRESCRIPTION NARCOTIC FOR THE PAIN BUT DID NOT CONTACT HER DOCTOR. THE PATIENT TREATED WITH THE DEVICE FOR 2 HOURS. IT WAS LATER REPORTED THAT THE PATIENT DISCUSSED THE PAIN ISSUE WITH HER DOCTOR AND WAS ADVISED TO DISCONTINUE USE. THE PHYSICIAN DID NOT PRESCRIBE OR RECOMMENDED ANYTHING ELSE FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

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.