BIOMET EBI BONE HEALING SYSTEM
Report
- Report Number
- 0002242816-2025-00123
- Event Type
- Injury
- Date Received
- October 15, 2025
- Report Date
- March 25, 2026
- Manufacturer
- EBI, LLC.
- Product Code
- LOF
- UDI-DI
- 00812301020560
- PMA / PMN Number
- P790002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION: B4- DATE OF THIS REPORT, G3- DATE RECEIVED BY MANUFACTURER, H2 ¿ FOLLOW UP TYPE. CORRECTED DATA: B2- OUTCOMES ATTRIBUTED TO ADVERSE EVENT, H4 - DEVICE MANUFACTURE DATE.
CORRECTIONS - B4: DATE OF THIS REPORT ADDED, D3: MANUFACTURER ADDRESS AND EMAIL ADDRESS, G1: CONTACT OFFICE AND MANUFACTURER SITE, G3, G6: REPORT TYPE, H6: IMPACT CODE. ADDITIONAL INFORMATION, H6: METHOD, H10: ADDITIONAL NARRATIVE, H11: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WAS NOT RETURNED TO EBI LLC FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LIMITED INFORMATION FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. EBI LLC WILL CONTINUE TO MONITOR FOR TRENDS.
B3 DATE OF EVENT: ESTIMATED DATE OF EVENT IS SEPTEMBER 2025. 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.
IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED PAIN WHILE TREATING. PATIENT SPOKE TO THE SALES REPRESENTATIVE AND HER DOCTOR WHO SUGGESTED THE TIME TEST AND EXPLAINED THE TIME TEST. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.
IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED PAIN WHILE TREATING. PATIENT SPOKE TO THE SALES REPRESENTATIVE AND HER DOCTOR WHO SUGGESTED THE TIME TEST AND EXPLAINED THE TIME TEST. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.
IT WAS REPORTED BY THE PATIENT THAT SHE EXPERIENCED PAIN WHILE TREATING. PATIENT SPOKE TO THE SALES REPRESENTATIVE AND HER DOCTOR WHO SUGGESTED THE TIME TEST AND EXPLAINED THE TIME TEST. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175766 | BIOMET EBI BONE HEALING SYSTEM | STIMULATOR, BONE GROWTH, NON-INVASIVE | LOF | EBI, LLC. | 1068234 | 00812301020560 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | SEE H10 NARRATIVE |