Elite EL-252007Y4Recalls & reported problems
Synthes GmbH · ELITE 25x20x7mm, Y-Shaped Bridge, 4 Legs · Class 2 · Implant
All models of Elite (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810633021798), received between May 23, 2019 and Jun 8, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 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
Device problems
- Manufacturing, Packaging or Shipping Problem3
- Break1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT STAPLE IS BROKEN. THIS COMPLAIN INVOLVES ONE(1) DEVICE ELITE COMP IMPL 25X20X20X20X20 4 LEGS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14632686 ↗MalfunctionFeb 19, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
UPDATED ED: IT WAS REPORTED ON (B)(6) 2020, AN ELITE COMPRESSION IMPLANT IN THE PACKAGE DOES NOT MATCHED ON THE LABEL OF THE PACKAGE. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9728512 ↗MalfunctionJun 13, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THE ISSUE WAS DETERMINED TO BE A LABELING ISSUE WHICH WAS DEEMED NOT REPORTABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8697358 ↗MalfunctionMay 23, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) ELITE COMPRESSION IMPLANTS WERE RECEIVED WITH PRODUCT PACKAGING ISSUE. THE BOX WAS INCORRECT. THE LABEL ON THE IMPLANT MATCHED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT 25X20X20X20X20 4 LEGS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8636611 ↗
Other Staple, Fixation, Bone devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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