BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

B4 EVENT DATE: ESTIMATED DATE OF EVENT IS MAY 2025. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

Description of Event or Problem

IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT INDICATED THE UNIT GAVE HORRIBLE CONSTANT MUSCLE CONTRACTIONS. ADDITIONALLY, THE PATIENT MENTIONED THAT SHE HAS ALWAYS HAD SPASMS ON HER BACK SINCE SURGERY. HOWEVER, SHE SAID WHEN SHE WEARS THE STIMULATOR, IT INCREASES HER SPASMS TIMES 10. THE PATIENT WAS ADVISED TO TRY AND DO A SLOW ROLL OUT WITH THE STIMULATOR AND SLOWLY ADD AN HOUR EACH DAY. NO FURTHER CONSEQUENCES WERE REPORTED. SPINALPAK ASSEMBLY WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT INDICATED THE UNIT GAVE HORRIBLE CONSTANT MUSCLE CONTRACTIONS. ADDITIONALLY THE PATIENT MENTIONED THAT SHE HAS ALWAYS HAD SPASMS ON HER BACK SINCE SURGERY. HOWEVER SHE SAID WHEN SHE WEARS THE STIMULATOR, IT INCREASES HER SPASMS TIMES 10. THE PATIENT WAS ADVISED TO TRY AND DO A SLOW ROLL OUT WITH THE STIMULATOR AND SLOWLY ADD AN HOUR EACH DAY. NO FURTHER CONSEQUENCES WERE REPORTED. SPINALPAK ASSEMBLY WAS NOT RETURNED.

Additional Manufacturer Narrative

B3 EVENT DATE: ESTIMATED DATE OF EVENT IS (B)(6) 2025. ADDITIONAL INFORMATION: B4: DATE OF THIS REPORT, RECEIVED BY MANUFACTURER, H6: EVALUATION CODES. CORRECTED DATA: B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENT, H6: COMPONENT CODE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WAS NOT RETURNED TO EBI 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. THE DEVICE IS USED FOR TREATMENT. RELATED MANUFACTURER'S REPORT: MFR# 0002242816-2025-00079.