BIOMET EBI BONE HEALING SYSTEM
Received Aug 6, 2025
Report 0002242816-2025-00096 · MDR key 22730852
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
39 YR · Female
- 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
IT WAS REPORTED BY THE PATIENT THAT SHE IS IN A LOT OF PAIN WHILE TREATING AND SOME HEAT. THE SALES REP SUGGESTED TIME TEST, THE PATIENT WILL START WITH 1 HOUR FOR 2 DAYS AND THEN INCREASE. CUSTOMER SERVICE CALLED THE PATIENT REGARDING THE PAIN AND HEAT. THE PATIENT SAID SHE WAS AT WORK AND REQUEST A CALL BACK AT ANOTHER TIME. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IN THE FOLLOWING FIELDS - B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER. H2: FOLLOW UP TYPE, H6: EVALUATION CODES. CORRECTED DATA IN THE FOLLOWING FIELDS - H6: DEVICE CODE. 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.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT SHE IS IN A LOT OF PAIN WHILE TREATING AND SOME HEAT. THE SALES REP SUGGESTED TIME TEST, THE PATIENT WILL START WITH 1 HOUR FOR 2 DAYS AND THEN INCREASE. CUSTOMER SERVICE CALLED THE PATIENT REGARDING THE PAIN AND HEAT. THE PATIENT SAID SHE WAS AT WORK AND REQUEST A CALL BACK AT ANOTHER TIME. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.