BIOMET EBI BONE HEALING SYSTEM SFLX- XL THERAPEUTIC TREATMENT COILETTE
Received Sep 2, 2025 · Event occurred Aug 6, 2025
Report 0002242816-2025-00109 · MDR key 22937385
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
54 YR · Unknown
- Pain
- Pain
Narrative
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 - D2: COMMON DEVICE NAME, D3: CATALOG NUMBER, H6: DEVICE CODE. SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS AUGUST OF 2025. 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 SALES REPRESENTATIVE THAT WHILE USING BHS UNIT, THE PATIENT FELT THE UNIT, AND IT WAS PAINFUL AFTERWARDS. THE PATIENT STATED THAT THEY HAD SHARP PAIN IN FOOT AND PAIN LEVEL WAS AT 10 ON A SCALE OF 1-10. THE PAIN SUBSIDED WHEN THE PATIENT WAS NOT TREATED. THE PATIENT DID NOT INCREASE ANY ACTIVITY. THE PATIENT SPOKE TO THEIR DOCTOR WHO ADVISED THEM TO STOP TREATING OVER THE WEEKEND AND WOULD SWITCH THE PATIENT TO DIFFERENT UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE BHS ASSEMBLY AND SFLX XL COILETTE WERE NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT WHILE USING BHS UNIT, THE PATIENT FELT THE UNIT, AND IT WAS PAINFUL AFTERWARDS. THE PATIENT STATED THAT THEY HAD SHARP PAIN IN FOOT AND PAIN LEVEL WAS AT 10 ON A SCALE OF 1-10. THE PAIN SUBSIDED WHEN THE PATIENT WAS NOT TREATED. THE PATIENT DID NOT INCREASE ANY ACTIVITY. THE PATIENT SPOKE TO THEIR DOCTOR WHO ADVISED THEM TO STOP TREATING OVER THE WEEKEND AND WOULD SWITCH THE PATIENT TO DIFFERENT UNIT. NO FURTHER CONSEQUENCES WERE REPORTED. THE BHS ASSEMBLY AND SFLX XL COILETTE WERE NOT RETURNED.
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. THIS REPORT IS RELATED TO MFR NUMBER: 0002242816-2025-00108.