BIOMET EBI BONE HEALING SYSTEM
Received May 13, 2026
Report 0002242816-2026-00063 · MDR key 25159082
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Pain
Narrative
Additional Manufacturer Narrative
SECTION B3: AS THE DATE OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS (B)(6) 2026 SECTION D4: THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. H4: AS THE LOT NUMBER OF THE PRODUCT IS UNKNOWN, THE DATE OF MANUFACTURE CAN NOT BE DETERMINED. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT¿S FOOT HURT DURING TREATMENT. THE PATIENT STATED THAT THE PAIN STARTED A FEW DAYS AFTER RECEIVING THE UNIT. THE PATIENT RATED THE PAIN LEVEL A 12 OUT OF 10 WITH 10 BEING THE HIGHEST. THE PAIN SUBSIDED WHEN THE PATIENT PAUSED TREATMENT. THE PATIENT DID NOT DISCUSS THE ISSUE WITH THEIR DOCTOR AND IS TAKING IBUPROFEN FOR THE PAIN. NO FURTHER INFORMATION WAS PROVIDED.