TriLeap Lower Extremity Anatomic Plating System Lapidus Ti Plate 0 mm Step, RightRecalls & reported problems
Crossroads Extremity Systems · Lapidus Ti Plate 0 mm Step, 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
- 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 00810112595789), received between Dec 3, 2024 and Dec 3, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 Incompatibility4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED WHILE USING A RIGHT LAPIDUS- RT 0MM STEP PLATE IN A SURGERY, SEVERAL 3.5MM VA LOCKING SCREWS WERE UNABLE TO THREAD INTO CENTRAL HOLE OF PLATE. THE 2.7 DRILL BIT WAS USED WITH CONE GUIDE. 18MM 3.5 VA LOCKER WAS UNABLE TO THREAD INTO PLATE. FIRST CORTEX WAS RE-DRILLED. 20MM 3.5 VA LOCKER WAS USED, WAS AGAIN UNABLE TO THREAD INTO PLATE. 4.0 20MM VA LOCKER WAS THEN USED, SCREW WAS UNABLE TO THREAD INTO PLATE. HOLE WAS LEFT UNFILLED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832704 ↗MalfunctionDec 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED WHILE USING A RIGHT LAPIDUS- RT 0MM STEP PLATE IN A SURGERY, SEVERAL 3.5MM VA LOCKING SCREWS WERE UNABLE TO THREAD INTO CENTRAL HOLE OF PLATE. THE 2.7 DRILL BIT WAS USED WITH CONE GUIDE. 18MM 3.5 VA LOCKER WAS UNABLE TO THREAD INTO PLATE. FIRST CORTEX WAS RE-DRILLED. 20MM 3.5 VA LOCKER WAS USED, WAS AGAIN UNABLE TO THREAD INTO PLATE. 4.0 20MM VA LOCKER WAS THEN USED, SCREW WAS UNABLE TO THREAD INTO PLATE. HOLE WAS LEFT UNFILLED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832702 ↗MalfunctionDec 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED WHILE USING A RIGHT LAPIDUS- RT 0MM STEP PLATE IN A SURGERY, SEVERAL 3.5MM VA LOCKING SCREWS WERE UNABLE TO THREAD INTO CENTRAL HOLE OF PLATE. THE 2.7 DRILL BIT WAS USED WITH CONE GUIDE. 18MM 3.5 VA LOCKER WAS UNABLE TO THREAD INTO PLATE. FIRST CORTEX WAS RE-DRILLED. 20MM 3.5 VA LOCKER WAS USED, WAS AGAIN UNABLE TO THREAD INTO PLATE. 4.0 20MM VA LOCKER WAS THEN USED, SCREW WAS UNABLE TO THREAD INTO PLATE. HOLE WAS LEFT UNFILLED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832699 ↗MalfunctionDec 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED WHILE USING A RIGHT LAPIDUS- RT 0MM STEP PLATE IN A SURGERY, SEVERAL 3.5MM VA LOCKING SCREWS WERE UNABLE TO THREAD INTO CENTRAL HOLE OF PLATE. THE 2.7 DRILL BIT WAS USED WITH CONE GUIDE. 18MM 3.5 VA LOCKER WAS UNABLE TO THREAD INTO PLATE. FIRST CORTEX WAS RE-DRILLED. 20MM 3.5 VA LOCKER WAS USED, WAS AGAIN UNABLE TO THREAD INTO PLATE. 4.0 20MM VA LOCKER WAS THEN USED, SCREW WAS UNABLE TO THREAD INTO PLATE. HOLE WAS LEFT UNFILLED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832696 ↗
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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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