Biomet EBI Bone Healing System 1068233Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812301020553), received between Apr 29, 2020 and May 26, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND A BURNING SENSATION FROM USING THE BONE HEALING SYSTEM (BHS) WITH THE SFLX COILETTE. THE PATIENT WAS TREATING HER LEFT FOOT WITH THE DEVICE DURING THE NIGHT. THE PATIENT SAID THAT WHEN SHE FIRST STARTED TREATMENT, SHE WOULD WAKE UP IN PAIN AFTER 7 OR 8 HOURS. THE PATIENT REPORTED THAT THE PAIN WAS AN 8, ON A SCALE OF 1 TO 10. THE PATIENT DESCRIBED THE PAIN AS DEEP AND BELOW THE SURFACE OF THE SKIN. THE PATIENT SAID THAT THE PAIN SUBSIDES AFTER 30 TO 60 MINUTES AND THEN SHE CAN FALL BACK ASLEEP. A FEW DAYS LATER, AFTER 3 TO 5 HOURS OF TREATING, THE PATIENT WOKE FROM A SEARING BURNING SENSATION. THE PATIENT SAID THAT HER SKIN WAS NOT RED AND THE COILETTE WAS NOT HOT. THE PATIENT TRIED TREATING WITHOUT A SOCK UNDERNEATH THE COIL AND THE PATIENT STILL EXPERIENCED THE BURNING SENSATION. THE PATIENT HAD AN APPOINTMENT WITH HER DOCTOR AND WAS PROVIDED WITH A REPLACEMENT BHS CONTROLLER AND COILETTE FOR TREATMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Burning Sensation; Pain

  MAUDE report 10086643 ↗
• InjuryApr 29, 2020Overheating of Device; Insufficient Device Problem Information; Overheating of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A BURN FROM USING THE BONE HEALING SYSTEM (BHS). THE PATIENT WORE THE COIL DIRECTLY ON THE LEFT FOOT FOR A FIFTH METATARSAL INJURY. THE PATIENT WORE THE UNIT FOR TEN HOURS A DAY DURING THE NIGHT. WHEN THE PATIENT BEGAN TREATING WITH THE DEVICE, SHE DID NOT EXPERIENCE ANY SYMPTOMS. THE PATIENT NOTICED A RED MARK BELOW THE JOINT OF THE FIFTH METATARSAL OF THE LEFT FOOT. THE PATIENT SAID THAT THE MORE SHE WORE THE COIL, THE WORSE THE RED MARK GOT. EVENTUALLY, THE RED MARK DEVELOPED INTO A BLISTER. THE PATIENT APPLIED A BAND AID TO THE BLISTER AND LEFT IT FOR ABOUT A WEEK. WHEN THE PATIENT TOOK OFF THE BAND AID SHE NOTICED THAT THE BLISTER HAD GOTTEN PROGRESSIVELY WORSE. THE PATIENT CONTACTED HER DOCTOR AND WAS ADVISED TO GO TO A WOUND CLINIC AND TO STOP USING THE UNIT. THE PATIENT ALSO STATED THAT HER FOURTH AND FIFTH METATARSAL WOULD TWITCH WHILE USING THE UNIT. THE PATIENT SAID THAT THE BHS CONTROLLER WOULD GET HOT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 10010891 ↗