TriLeap Lower Extremity Anatomic Plating System 3.0 mm Ti Variable Angle Screw Length 12 mm, Rose RedRecalls & reported problems
Crossroads Extremity Systems · 3.0 mm Ti Variable Angle Screw Length 12 mm, Rose Red · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810112594300), received between Jan 3, 2025 and Jan 3, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. LOCKING SCREWS OF ALL SIZES WOULD NOT LOCK INTO THE MTP PLATES. LOCKING SCREW HEADS WOULD NOT ENGAGE WITH THE LOCKING THREADS IN THE PLATE. SCREW IS HITTING NEAR CORTEX BEFORE SITTING LOW ENOUGH TO ENGAGE. THIS WAS TRIED MULTIPLE TIMES WITH DIFFERENT PLATES AND SCREWS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. PATIENT HAS PROMINENT HARDWARE.
Patient problems: Insufficient Information
MAUDE report 21070382 ↗MalfunctionJan 3, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. LOCKING SCREWS OF ALL SIZES WOULD NOT LOCK INTO THE MTP PLATES. LOCKING SCREW HEADS WOULD NOT ENGAGE WITH THE LOCKING THREADS IN THE PLATE. SCREW IS HITTING NEAR CORTEX BEFORE SITTING LOW ENOUGH TO ENGAGE. THIS WAS TRIED MULTIPLE TIMES WITH DIFFERENT PLATES AND SCREWS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. PATIENT HAS PROMINENT HARDWARE.
Patient problems: Insufficient Information
MAUDE report 21070374 ↗
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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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