BIOMET EBI BONE HEALING SYSTEM
Received Jun 22, 2026
Report 0002242816-2026-00078 · MDR key 25580370
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pain
Narrative
Additional Manufacturer Narrative
SECTION B3: THE DATE OF THE EVENT IS UNKNOWN AND IS ESTIMATED TO HAVE OCCURRED IN MAY OF 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. 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
THE SALES REP ADVISED THAT THE PATIENT HAD PAIN WHILE USING THE BHS. THE PATIENT WAS CALLED TO COLLECT ADDITIONAL INFORMATION BUT A VOICEMAIL HAD TO BE LEFT. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT.