BIOMET EBI BONE HEALING SYSTEM
Received Apr 23, 2026
Report 0002242816-2026-00053 · MDR key 24965867
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
56 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
THE SALES REP ADVISED THAT THE PATIENT HAD AN ACHEY FEELING WHEN TREATING. THE PATIENT WAS CALLED AND ADVISED THAT SHE WORE THE UNIT 10 HOURS A DAY. SHE DID NOT CALL HER DOCTOR BECAUSE IT WAS NOT SEVERE. THE PAIN HAS NOT STOPPED HER FROM WEARING THE UNIT. SHE DOESN'T BELIEVE THAT THE PAIN WAS FROM THE UNIT, SHE BELIEVES THE PAIN IS FROM HEALING AS SHE IS SENSITIVE. THE PATIENT WILL CONDUCT A TIMED TEST AND CALL BACK IF THERE ARE ANY ISSUES. NO NEW PRODUCT WAS SHIPPED TO THE PATIENT.