BIOMET EBI BONE HEALING SYSTEM
Received Sep 15, 2025
Report 0002242816-2025-00116 · MDR key 23051353
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER, H2, H10, H11. CORRECTED DATA: D3: EMAIL ADDRESS, G1: EMAIL ADDRESS. SECTION B3: AS THE ONSET DATE OF THE PAIN IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS 2025. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WAS NOT RETURNED TO EBI FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. THE DEVICE IS USED FOR TREATMENT. EBI WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT IT WAS PAINFUL TO USE THE DEVICE FOR MORE THAN 45 MINUTES STRAIGHT. THE PATIENT STATED IT FELT PAINFUL, AS IF THEIR FOOT WAS BEING SQUEEZED AND THE METALS THAT WERE PLACED INSIDE WERE BEING PULLED OUT. THE PATIENT MENTIONED IT TO THEIR DOCTOR AND WAS ADVISED TO CONTACT THE SALES REPRESENTATIVE. NO FURTHER INFORMATION WAS PROVIDED.
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.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT IT WAS PAINFUL TO USE THE DEVICE FOR MORE THAN 45 MINUTES STRAIGHT. THE PATIENT STATED IT FELT PAINFUL, AS IF THEIR FOOT WAS BEING SQUEEZED AND THE METALS THAT WERE PLACED INSIDE WERE BEING PULLED OUT. THE PATIENT MENTIONED IT TO THEIR DOCTOR AND WAS ADVISED TO CONTACT THE SALES REPRESENTATIVE. NO FURTHER INFORMATION WAS PROVIDED.