BIOMET EBI BONE HEALING SYSTEM
Received Nov 20, 2025
Report 0002242816-2025-00149 · MDR key 23605087
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
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 (B)(6) 2025.
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 D4- THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. H4- THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED AS THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. 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 UNABLE TO BE REVIEWED AS THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. 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.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B4- DATE OF THIS REPORT, G3- DATE RECEIVED BY MANUFACTURER, H2 ¿ FOLLOW UP TYPE CORRECTED DATA: D2 ¿ COMMON DEVICE NAME 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.
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