Biomet EBI Bone Healing System 1068228Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812301020539), received between Jan 21, 2020 and Jan 17, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2024Patient-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 DEVICE (COIL) WAS HURTING THE PATIENT. THE PATIENT STATED THAT THE UNIT WAKES HIM UP WHEN SLEEPING. THE PATIENT STATED THAT THE PAIN STARTED 3 DAYS AFTER HE GOT THE DEVICE (COIL). THE PATIENT WAS TOLD BY THE SALES REPRESENTATIVE NOT TO USE THE UNIT FOR 2 DAYS. THE PATIENT WAS USING THE DEVICE 10 HOURS A DAY. THE PATIENT STATED THAT THE PAIN IS IN THE BONE. THE PATIENT DID NOT SPEAK TO THE DOCTOR. THE PATIENT HAS NOT INCREASED HIS DAILY ACTIVITY. THE PATIENT STATED THAT THE PAIN LEVEL IS A 10 OUT OF 10. THE PATIENT STATED THAT IT TOOK ABOUT 24 HOURS FOR THE PAIN TO GO AWAY AFTER HE STOPPED USING THE DEVICE (COIL). THE PATIENT WAS TOLD TO WAIT UNTIL HIS PAIN WAS COMPLETELY GONE AND THEN HE COULD START DOING THE TIME TEST. THE PATIENT WILL CALL BACK WITH AN UPDATE. LATER, IT WAS REPORTED THAT THE PATIENT IS STILL HAVING PAIN AND DISCOMFORT FROM THE DEVICE. THE SALES REPRESENTATIVE STATED THAT THE DOCTOR WOULD LIKE THE PATIENT TO TREAT WITH THE BONE STIMULATOR FOR 2 MONTHS. THE SALES REPRESENTATIVE SUGGESTED THE PATIENT TRY THE ORTHOPAK AS HE IS SAYING HE CAN'T USE THE BHS.

  Patient problems: Pain

  MAUDE report 18530857 ↗
• InjuryJan 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS BECOMING SORE FROM USING THE BONE HEALING SYSTEM (BHS) SFLX 2-4 COIL. THE PATIENT GOT THE BHS FOR HIS LEFT FOOT AND WAS WEARING THE COIL UNDER HIS BOOT. THE PATIENT STATED THAT WHEN HE REMOVED THE SFLX 2-4 COIL, IT LOOKED LIKE THERE WAS A HOLE IN HIS FOOT ABOUT 1 INCH DEEP WHERE THE ANKLE MEETS THE FOOT AND ANOTHER HOLE ABOUT THE SIZE OF A DIME ON HIS BIG TOE. THE PATIENT SAW THE DOCTOR AND WAS PRESCRIBED MUPIROCIN OINTMENT. THE REDNESS HAS SINCE CALMED DOWN AND THE DOCTOR WANTS THE PATIENT TO SWITCH TO A DIFFERENT DEVICE FOR TREATMENT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Code Available

  MAUDE report 9610232 ↗