BIOMET EBI BONE HEALING SYSTEM
Received Jan 5, 2026
Report 0002242816-2026-00157 · MDR key 23961422
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
30 YR · Unknown
- Pain
Narrative
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, 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.
Description of Event or Problem
THE PATIENT REPORTED SHE WAS IN A LOT OF PAIN WHILE TREATING. THE PATIENT STATED THAT SHE WORE THE UNIT FOR 5 HOURS. THEN TOOK A BREAK FOR A FEW HOURS. THEN WORE IT AGAIN FOR 90 MINUTES AND BEGAN FEELING PAIN. THE PATIENT DID NOT TELL THE DOCTOR, ONLY THE SALES REP. THE PATIENT WILL CONDUCT THE TIME TEST AND CALL BACK WITH ANY ISSUES. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURN FOR FURTHER EVALUATION.
Description of Event or Problem
THE PATIENT REPORTED SHE WAS IN A LOT OF PAIN WHILE TREATING. THE PATIENT STATED THAT SHE WORE THE UNIT FOR 5 HOURS. THEN TOOK A BREAK FOR A FEW HOURS. THEN WORE IT AGAIN FOR 90 MINUTES AND BEGAN FEELING PAIN. THE PATIENT DID NOT TELL THE DOCTOR, ONLY THE SALES REP. THE PATIENT WILL CONDUCT THE TIME TEST AND CALL BACK WITH ANY ISSUES. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURN FOR FURTHER EVALUATION.
Additional Manufacturer Narrative
SECTION B3: THE DATE OF THE EVENT IS UNKNOWN AND IS ESTIMATED TO HAVE OCCURRED IN DECEMBER 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.