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Biomet EBI Bone Healing System 1068227Recalls & reported problems

Ebi, LLC · SFLX 2-1 COIL · Class 2

All models of Biomet EBI Bone Healing System (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812301020522), received between Aug 6, 2020 and Aug 6, 2020 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    IT WAS REPORTED BY THE SALES REP THAT THE PATIENT IS EXPERIENCING PAIN WITHIN ONE TO TWO MINUTES OF USING THE BHS UNIT. THE PAIN WAS IMMEDIATELY. THE PAIN LEVEL IS ABOUT A SEVEN. THE PAIN IS BELOW THE SKIN. THE FIRST DAY SHE USED THE UNIT FOR ABOUT 6 HOURS. THE SECOND DAY IT WAS USED FOR 10 HOURS AND THE THIRD DAY SHE USED IT FOR 8 HOURS. THE PATIENT CONTINUED TO USE THE UNIT BECAUSE SHE WAS NOT SURE IF SHE WAS SUPPOSED TO FEEL THE PAIN. THE PAIN SUBSIDES QUITE A BIT ALMOST IMMEDIATELY WHEN SHE TURNS OFF THE MACHINE. FROM A LEVEL 7 TO LEVEL 4. BUT THE PATIENT STILL HAS RESIDUAL PAIN. THE PAIN COMES AND GOES THROUGHOUT THE DAY. THE PATIENT WEARS THE UNIT AT NIGHT. THE PATIENT HAS NOT INCREASED HER DAILY ACTIVITY. THE PATIENT DID NOT SPEAK TO HER DOCTOR REGARDING THE PAIN. THE PATIENT HAS NOT TAKEN ANYTHING FOR THE PAIN. I TOLD THE PATIENT TO CONTACT HER DOCTOR. CALLED THE PATIENT AND SHE SAID SHE'S BEEN MORE ACTIVE LATELY. AND EVEN THOUGH SHE DID NOT WEAR THE UNIT LAST NIGHT, TODAY SHE'S BEEN ON HER FEET ALL DAY AND SHE IS IN PAIN. SHE WILL CALL HER DOCTOR AND CONDUCT A TIMED TEST. SHE WILL ALSO CALL US IF SHE HAS ANY OTHER ISSUES. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORT

    Patient problems: Pain

    MAUDE report 10374224 ↗

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Sources and updates

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