BIOMET EBI BONE HEALING SYSTEM
Received Mar 19, 2026
Report 0002242816-2026-00032 · MDR key 24638264
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR · Female
- Pain
Narrative
Additional Manufacturer Narrative
WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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.
Description of Event or Problem
IT WAS REPORTED BY THE SALES REPRESENTATIVE (B)(6) THAT THE PATIENT REPORTED PAIN WHILE TREATING WITH THE BHS. (B)(6) WONDERED IF SWITCHING TO AN OPAK WAS AN OPTION. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND THE PAIN STARTED IN DECEMBER. THE PAIN STARTS WITHIN 10 MINUTES INTO TREATMENT. THE PATIENT DID NOT KNOW IF IT WAS FROM THE STIMULATOR OR HER FOOT. WHEN THE UNIT IS REMOVED THE PAIN GOES AWAY WITHIN 30 MINUTES TO AN HOUR. THE PATIENT HAS CONSTANT PAIN. THE PAIN INCREASES WHILE TREATING. THE CONSTANT PAIN LEVEL IS A 6. WHEN USING THE STIMULATOR, THE PAIN IN CREASES TO A 10 OR 11. THE PATIENT TAKES HYDROCODONE ACETAMINOPHEN 10/325MG. THE DOCTOR IS AWARE OF THE PAIN. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITIES. THE PATIENT INDICATED THAT THE UNIT IS GOING TO BE SWITCHED. AN EMAIL WAS SENT TO MORGAN YOUNG. NO PRODUCT WAS SHIPPED. NO RETURN NOTED.