Biomet EBI Bone Healing System 1068239Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812301020614), received between Mar 16, 2023 and Jan 8, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAD TERRIBLE PAIN WHILE USING BHS UNIT. THE PATIENT LOOSENED THE COIL FOR RELIEF AND AFTER 30 MINUTES THE PAIN WAS TERRIBLE. THE PATIENT HAS A FRACTURE AND OSTEOMYELITIS. THE SALES REPRESENTATIVE TOLD THE PATIENT TO CONDUCT TIME-TEST USING THE UNIT. THE PATIENT WAS ADVISED TO TREAT FOR 30 MINUTES AND GRADUALLY INCREASED THE TIME. THE PATIENT DID NOT SEEK ANY MEDICAL TREATMENT. LATER, AS PER THE CUSTOMER SERVICE REPRESENTATIVE, AN EMAIL WAS RECEIVED FROM SALES REPRESENTATIVE STATING THAT THE PATIENT INDICATED THAT EVERYTHING IS GOING GREAT WITH HOURLY INCREASE WHILE CONDUCTING TIME-TEST. NO FURTHER CONSEQUENCES ARE REPORTED. THE SFLX-MINI COILETTE WERE NOT RETURNED FOR FURTHER EVALUATION.

  Patient problems: Pain

  MAUDE report 21104437 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN A LOT OF PAIN IN GENERAL. THE SALES REPRESENTATIVE REQUESTED AN SFLX COILETTE BE SHIPPED TO THE PATIENT SO THE COIL CAN LAY OVER THE FINGER INSTEAD OF BETWEEN THE FINGERS LIKE THE SFLX MINI COILETTE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20746635 ↗
• InjuryMar 16, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DOCTOR'S NOTE MENTIONED PAIN. THE PATIENT HAS BEEN EXPERIENCING PAIN WITH THE DEVICE AND THE SFLX MINI COILETTE BUT THOUGHT THE PAIN WAS FROM THE SURGERY. THE PATIENT STATED THAT THE PAIN WAS FROM THE MIDDLE OF THE NINE-MONTH TREATMENT UNTIL THE END. THE PATIENT HAS A NON-UNION FRACTURE AND IS GOING TO HAVE SURGERY AGAIN IN MARCH. THE PATIENT STATED THAT HER PREVIOUS SURGERY WAS "DONE WRONG" AND THAT A BONE WILL BE TAKEN OUT OF HER HIP. THE PATIENT WILL CONDUCT THE TIME TEST IF SHE HAS PAIN WITH THE NEW UNIT. SHE TOLD THE DOCTOR ABOUT THE PAIN WHICH IS WHY SHE IS HAVING REVISION SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE PATIENT. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 16558293 ↗