BIOMET SPINALPAK / ORTHOPAK
Received Jul 13, 2026
Report 0002242816-2026-00083 · MDR key 25797370
Device
Product problems
- Patient-Device Incompatibility
Patient
NA · Female
- Blister
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
B3: THE DATE OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS JUNE OF 2026. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION CAN 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. THE DEVICE IS USED FOR TREATMENT. EBI WILL CONTINUE TO MONITOR TRENDS.
Description of Event or Problem
THE PATIENT ADVISED THAT THE 63B ELECTRODES ARE MORE IRRITATING THAN THE 72R ELECTRODES. THE PATIENT ADVISED SHE HAS DEVELOPED BLISTERS ON HER SKIN WHEN TREATING MORE THAN 6 HOURS. HER DOCTOR GAVE HER A PRESCRIPTION CREAM TO USE. THE PATIENT'S DOCTOR ADVISED HER TO WITCH TO THE 72R ELECTRODES. THE PATIENT WILL PERFORM A TIME TEST WITH THE 72R ELECTRODES. NEW 72R ELECTRODES WERE SHIPPED TO THE PATIENT.