BIOMET EBI BONE HEALING SYSTEM
Received Mar 30, 2026
Report 0002242816-2026-00040 · MDR key 24728281
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
71 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
IT WAS REPORTED BY THE SALES REPRESENTATIVE (B)(6) THAT THE PATIENT HAD PAIN WHILE TREATING THE BHS. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT FOR DETAILS BUT HAD TO LEAVE A VOICEMAIL FOR A RETURN CALL. NO PRODUCT WAS SHIPPED. NO RETURN NOTED.