Elite EL-252513HRecalls & reported problems
Biomedical Enterprises, Inc. · ELITE 25x25x13mm, 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 00810633021750), received between Feb 27, 2019 and Feb 27, 2019 — 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
- Foreign Body In Patient1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT WAS IMPLANTED WITH AN ELITE "H" NITINOL CONTINUOUS COMPRESSION. ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO NONUNION. THE ELITE COMPRESSION IMPLANT 4 LEGS BROKE IN SITU AT THE LEGS AND THE BROKEN LEGS ARE LEFT INSIDE THE PATIENT BONE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: Foreign Body In Patient; Nonunion/Delayed-union Bone Fracture
MAUDE report 8375989 ↗
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- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- 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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