BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Nov 12, 2025
Report 0002242816-2025-00140 · MDR key 23532412
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Male
- Pain
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED A DULL ACHE WHILE USING THE DEVICE. THE PATIENT STATED THAT THEY EXPERIENCE PAIN WHETHER HE HAS THE UNIT ON OR NOT. THE PATIENT WORE THE DEVICE FOR 6 HOURS. THE PATIENT WAS PRESCRIBED PAIN MEDICATION AFTER THE SURGERY, BUT HE IS NOT TAKING THEM. THE PATIENT TAKES TYLENOL SOMETIMES. THE PATIENT DID NOT SPEAK WITH HIS DOCTOR, ONLY THE SALES REP. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.
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. SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS OCTOBER OF 2025.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED A DULL ACHE WHILE USING THE DEVICE. THE PATIENT STATED THAT THEY EXPERIENCE PAIN WHETHER HE HAS THE UNIT ON OR NOT. THE PATIENT WORE THE DEVICE FOR 6 HOURS. THE PATIENT WAS PRESCRIBED PAIN MEDICATION AFTER THE SURGERY, BUT HE IS NOT TAKING THEM. THE PATIENT TAKES TYLENOL SOMETIMES. THE PATIENT DID NOT SPEAK WITH HIS DOCTOR, ONLY THE SALES REP. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.
Additional Manufacturer Narrative
CORRECTIONS IN B4: DATE OF THE REPORT. ADDITIONAL INFORMATION IN H4: MANUFACTURE DATE, G3, H6 AND H10: ADDITIONAL NARRATIVE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE SPINALPAK CONTROLLER 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. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR TRENDS.