Elite EL-202513HRecalls & reported problems
Biomedical Enterprises, Inc. · ELITE 20x25x13mm, H-Shaped Bridge, 4 Legs · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810633021736), received between Sep 25, 2018 and Sep 25, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2018Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT HAD A FOLLOW-UP AND SURGEON NOTICED A BROKEN ELITE COMPRESSION IMPLANT AT THE TALUS-MEDIAL AND INTERMEDIATE CUNEIFORMS BASED ON AN X-RAY REVIEW. IT IS UNKNOWN WHEN THE DEVICE WAS ORIGINALLY IMPLANTED. PATIENT HAD NO COMPLAINTS OF PAIN OR ANY SYMPTOMS. THERE WAS NO REVISION PROCEDURE PERFORMED. THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT 20X25X25X25X25 4 LEGS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7905129 ↗
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- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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