BIOMET EBI BONE HEALING SYSTEM
Received Nov 21, 2025
Report 0002242816-2025-00151 · MDR key 23619293
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Numbness
- Numbness
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT¿S LEG WENT NUMB WITHIN THE FIRST 5 MINUTES OF TREATMENT. THE NUMBNESS RESOLVED ON ITS OWN WITHIN 5 TO 10 MINUTES OF REMOVING THE DEVICE. THE PATIENT CONTACTED THEIR PHYSICIAN AND WAS SWITCHED FROM THE BONE HEALING SYSTEM TO THE ORTHOPAK FOR TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION - B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER, H6: EVALUATION CODES. CORRECTED DATA ¿ H6: IMPACT CODE (4642 ADDED). 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.
Additional Manufacturer Narrative
SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS NOVEMBER OF 2025. SECTION D4: THE LOT NUMBER OF THE PRODUCT IS UNKNOWN AS THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. 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. RELATED MANUFACTURER'S REPORT: 0002242816-2025-00150.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT¿S LEG WENT NUMB WITHIN THE FIRST 5 MINUTES OF TREATMENT. THE NUMBNESS RESOLVED ON ITS OWN WITHIN 5 TO 10 MINUTES OF REMOVING THE DEVICE. THE PATIENT CONTACTED THEIR PHYSICIAN AND WAS SWITCHED FROM THE BONE HEALING SYSTEM TO THE ORTHOPAK FOR TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.