TriLeap Lower Extremity Anatomic Plating System 1st MTP Ti Fusion Plate, Small, 0 Deg, RightRecalls & reported problems
Crossroads Extremity Systems · 1st MTP Ti Fusion Plate, Small, 0 Deg, Right · Class 2 · Implant
All models of TriLeap Lower Extremity Anatomic Plating System (57)
Data updated Oct 18, 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 00810112595581), received between May 6, 2025 and May 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CASE WHILE USING THE TRILEAP 1ST MTP PLATE, THE SURGEON WAS NOT ABLE TO LOCK A 3.0 VA LOCKING SCREW INTO THE PLATE. IT WAS CONFIRMED THAT THE PROPER 2.0 DRILL BIT FOR THE 3.0 VA LOCKING SCREW WAS USED BUT THE SCREW DID NOT LOCK INTO THE PLATE. THE SURGEONS WERE ABLE TO TAKE THE SCREW OUT, REDRILL BY USING A 3.5 DRILL BIT TO OVER DRILL THE HOLE AND TO HELP WITH COUNTER SINKING THE SCREW. AFTER COMPLETING THAT THEY WERE ABLE TO GET THE SCREW TO LOCK INTO THE PLATE. SO NO PATIENT WAS AFFECTED IN THE CASE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21971730 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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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