BIOMET EBI BONE HEALING SYSTEM
Received May 12, 2025 · Event occurred Apr 13, 2025
Report 0002242816-2025-00067 · MDR key 22002243
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
51 YR · Female
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
SECTION B3: AS THE ONSET DATE OF THE PAIN IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS (B)(6) OF 2025. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT IS HAVING PAIN WHILE WEARING A BHS COIL. SHE IS NOT MAKING IT TOO TIGHT. THE PATIENT STATED THAT THE ELECTROMAGNETIC FIELD (EMF) IS CAUSING HER PAIN. THE PAIN STARTS AS SOON AS SHE STARTS WEARING THE DEVICE AND IF SHE SHUTS THE DEVICE OFF, THE PAIN GOES AWAY. THE PATIENT STATED THAT THE PAIN STARTED WHEN SHE FIRST WORE THE DEVICE. THE PAIN IS BELOW THE SURFACE OF HER SKIN AND SUBSIDES WHEN SHE IS NOT USING THE DEVICE. THE PAIN LEVEL WAS RATED A 5 OUT OF 10, WITH 10 BEING THE WORST. THE PATIENT HAS NOT INCREASED HER DAILY LEVEL OF ACTIVITY. THE PATIENT WAS ADVISED BY CUSTOMER SERVICE TO CONDUCT A TIME TEST AND CALL BACK WITH ANY ISSUES. IT WAS LATER REPORTED ON 22APRIL2025 THAT THE PATIENT DISCUSSED THE PAIN WITH HER DOCTOR WHO RECOMMENDED DECREASING TREATMENT TIME. THE PATIENT IS ONLY USING THE UNIT FOR A COUPLE OF HOURS PER DAY COMPARED TO THE 10 HOURS PER DAY PREVIOUSLY. THE PATIENT STATED THAT WITH THE DECREASED TREATMENT TIME, THE PAIN LEVEL IS ABOUT 3 OUT OF 10. THE PATIENT IS COMFORTABLE WITH CONTINUING TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT IS HAVING PAIN WHILE WEARING A BHS COIL. SHE IS NOT MAKING IT TOO TIGHT. THE PATIENT STATED THAT THE ELECTROMAGNETIC FIELD (EMF) IS CAUSING HER PAIN. THE PAIN STARTS AS SOON AS SHE STARTS WEARING THE DEVICE AND IF SHE SHUTS THE DEVICE OFF, THE PAIN GOES AWAY. THE PATIENT STATED THAT THE PAIN STARTED WHEN SHE FIRST WORE THE DEVICE. THE PAIN IS BELOW THE SURFACE OF HER SKIN AND SUBSIDES WHEN SHE IS NOT USING THE DEVICE. THE PAIN LEVEL WAS RATED A 5 OUT OF 10, WITH 10 BEING THE WORST. THE PATIENT HAS NOT INCREASED HER DAILY LEVEL OF ACTIVITY. THE PATIENT WAS ADVISED BY CUSTOMER SERVICE TO CONDUCT A TIME TEST AND CALL BACK WITH ANY ISSUES. IT WAS LATER REPORTED, ON 22APRIL2025, THAT THE PATIENT DISCUSSED THE PAIN WITH HER DOCTOR WHO RECOMMENDED DECREASING TREATMENT TIME. THE PATIENT IS ONLY USING THE UNIT FOR A COUPLE OF HOURS PER DAY COMPARED TO THE 10 HOURS PER DAY PREVIOUSLY. THE PATIENT STATED THAT WITH THE DECREASED TREATMENT TIME, THE PAIN LEVEL IS ABOUT 3 OUT OF 10. THE PATIENT IS COMFORTABLE WITH CONTINUING TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
SECTION B3: AS THE ONSET DATE OF THE PAIN IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS (B)(6) 2025. 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.