BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM
Received Oct 28, 2025
Report 0002242816-2025-00137 · MDR key 23404232
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
76 YR · Male
- Pain
- Pain
Narrative
Description of Event or Problem
THE PATIENT REPORTED THAT THEY EXPERIENCED SHOOTING PAINS WHILE TREATING WITH THE BONE STIMULATOR. PATIENT STATED HE WAS TREATING HIS RIGHT BIG TOE WHEN HE WAS SLEEPING AND THEN ONCE WHEN HE WAS AWAKE. BOTH TIMES HE EXPERIENCED SHARP SHOOTING PAINS ON THE OUTSIDE OF HIS RIGHT THIGH EVERY COUPLE OF SECONDS. THE PAIN WAS CONSTANT UNTIL HE STOPPED TREATMENT. 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.
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 (B)(6) 2025.
Description of Event or Problem
THE PATIENT REPORTED THAT THEY EXPERIENCED SHOOTING PAINS WHILE TREATING WITH THE BONE STIMULATOR. PATIENT STATED HE WAS TREATING HIS RIGHT BIG TOE WHEN HE WAS SLEEPING AND THEN ONCE WHEN HE WAS AWAKE. BOTH TIMES HE EXPERIENCED SHARP SHOOTING PAINS ON THE OUTSIDE OF HIS RIGHT THIGH EVERY COUPLE OF SECONDS. THE PAIN WAS CONSTANT UNTIL HE STOPPED TREATMENT. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.