BIOMET EBI BONE HEALING SYSTEM
Received Apr 10, 2026
Report 0002242816-2026-00048 · MDR key 24845665
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
16 YR · Male
- Pain
- Swelling/ Edema
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 MARCH 2026.
Description of Event or Problem
THE PATIENT¿S MOTHER REPORTED THAT THEIR ANKLE HAS BEEN SWOLLEN SINCE STARTING TO TREAT WITH THE DEVICE. THE COIL IS NOT TOO TIGHT. ON (B)(6) 2026, THE PATIENT¿S MOTHER SPOKE TO CUSTOMER SERVICE AND STATED HER SON HAD SWELLING AND PAIN, AND HE WAS NOT ABLE TO WALK. THE PATIENT HAS NOT INCREASED HIS DAILY ACTIVITIES. THE PATIENT WORKS AND STANDS. THE PATIENT USED ICE ON HIS FOOT AND TOOK IBUPROFEN. THEY DID NOT CALL THE DOCTOR. THE PAIN LEVEL WAS A 10, AND THE PATIENT COULD BARELY WALK. THE PATIENT WILL CONDUCT THE TIME TEST AND CAN CALL BACK IF THERE ARE ANY ISSUES. NO REPLACEMENT PRODUCT WAS SHIPPED. NO FURTHER CONSEQUENCES ARE REPORTED.