BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received May 13, 2025
Report 0002242816-2025-00070 · MDR key 22013757
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR · Male
- Pain
- Pain
Narrative
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 APRIL OF 2025.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT HE EXPERIENCED NUMBNESS AND PAIN WHILE TREATING AND WHEN HE REMOVES THE ELECTRODES IT TENDS TO GO AWAY. PATIENT WAS ADVISED TO LIMIT TREATING FOR A LITTLE BIT AND TO REACH BACK OUT WITH AN UPDATE. THE PATIENT STATED HE HAS EXPERIENCED THIS FROM THE START, SO IT MAY NOT HAVE ANYTHING TO DO WITH THE BONE STIMULATOR. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT HE EXPERIENCED NUMBNESS AND PAIN WHILE TREATING AND WHEN HE REMOVES THE ELECTRODES IT TENDS TO GO AWAY. PATIENT WAS ADVISED TO LIMIT TREATING FOR A LITTLE BIT AND TO REACH BACK OUT WITH AN UPDATE. THE PATIENT STATED HE HAS EXPERIENCED THIS FROM THE START, SO IT MAY NOT HAVE ANYTHING TO DO WITH THE BONE STIMULATOR. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION - H4: DEVICE MANUFACTURE DATE, 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.