BIOMET EBI BONE HEALING SYSTEM
Received Mar 17, 2026
Report 0002242816-2026-00029 · MDR key 24616629
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
27 YR · Unknown
- Pain
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 FEBRUARY 2026.
Description of Event or Problem
THE PATIENT REPORTED EXPERIENCING PAIN WHILE TREATING. THE SALES REP ADVISED THE PATIENT TO STOP WEARING THE UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE BHS ASSEMBLY WAS NOT RETURNED.