BIOMET EBI BONE HEALING SYSTEM
Received Sep 8, 2025
Report 0002242816-2025-00113 · MDR key 22999329
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Pain
- 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 THAT THE PATIENT EXPERIENCED TERRIBLE PAIN DURING THE NIGHT THAT OFTEN WOKE HER UP. THE PATIENT BELIEVES IT IS THE BONE GROWTH STIMULATOR. THE PATIENT WEARS THE DEVICE FROM 8PM TO 6AM EVERY NIGHT. ON (B)(6) 2025, THE PATIENT REMOVED THE DEVICE AT MIDNIGHT BECAUSE HER FOOT HURT SO MUCH AND REALIZED AFTER ABOUT 30 MINUTES SHE HAD NO PAIN. THE PATIENT STATED THAT SHE DOES NOT EXPERIENCE ANY PAIN DURING THE DAY. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
SECTION B3: THE ONSET DATE OF THE PAIN IS UNKNOWN. THE EVENT IS ESTIMATED AS 2025. ADDITIONAL INFORMATION: B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER, H2, H6: EVALUATION CODES, H10, H11. CORRECTED DATA: D3: EMAIL ADDRESS, G1: 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. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. 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 FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TERRIBLE PAIN DURING THE NIGHT THAT OFTEN WOKE HER UP. THE PATIENT BELIEVES IT IS THE BONE GROWTH STIMULATOR. THE PATIENT WEARS THE DEVICE FROM 8PM TO 6AM EVERY NIGHT. ON (B)(6) 2025, THE PATIENT REMOVED THE DEVICE AT MIDNIGHT BECAUSE HER FOOT HURT SO MUCH AND REALIZED AFTER ABOUT 30 MINUTES SHE HAD NO PAIN. THE PATIENT STATED THAT SHE DOES NOT EXPERIENCE ANY PAIN DURING THE DAY. NO FURTHER INFORMATION WAS PROVIDED.