BIOMET EBI BONE HEALING SYSTEM
Received Nov 20, 2025
Report 0002242816-2025-00148 · MDR key 23604397
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
58 YR · Male
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
SECTION B3: THE DATE OF THE EVENT IS UNKNOWN AND IS ESTIMATED TO HAVE OCCURRED IN NOVEMBER OF 2025. 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 PATIENT REPORTED FEELING PAIN AFTER HE TAKES THE UNIT OFF, AND HE IS MOVING AROUND. THE PATIENT WORE THE UNIT ON HIS FOOT FOR 10 HOURS FOR 8 DAYS. PATIENT DID NOT SPEAK TO HIS DOCTOR ONLY THE SALES REP. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B4- DATE OF THIS REPORT, G3- DATE RECEIVED BY MANUFACTURER, H2 ¿ FOLLOW UP TYPE CORRECTED DATA: D3- MANUFACTURER EMAIL ADDRESS 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 TRENDS.
Description of Event or Problem
THE PATIENT REPORTED FEELING PAIN AFTER HE TAKES THE UNIT OFF, AND HE IS MOVING AROUND. THE PATIENT WORE THE UNIT ON HIS FOOT FOR 10 HOURS FOR 8 DAYS. PATIENT DID NOT SPEAK TO HIS DOCTOR ONLY THE SALES REP. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.
Description of Event or Problem
THE PATIENT REPORTED FEELING PAIN AFTER HE TAKES THE UNIT OFF, AND HE IS MOVING AROUND. THE PATIENT WORE THE UNIT ON HIS FOOT FOR 10 HOURS FOR 8 DAYS. PATIENT DID NOT SPEAK TO HIS DOCTOR ONLY THE SALES REP. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B4- DATE OF THIS REPORT, G3- DATE RECEIVED BY MANUFACTURER, H2 ¿ FOLLOW UP TYPE CORRECTED DATA: G4-PMA/510(K)# THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. 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 TRENDS.