TriLeap Lower Extremity Anatomic Plating SystemRecalls & reported problems across all models
Crossroads Extremity Systems · 57 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 100
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 57 models of TriLeap Lower Extremity Anatomic Plating System by Crossroads Extremity Systems in the FDA's device registry (GUDID). Together they are named in 100 adverse event reports in the FDA's MAUDE database, received between Sep 12, 2024 and Sep 22, 2026 — classified as 100 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (54 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TriLeap Lower Extremity Anatomic Plating System problems
Device problems
- Device-Device Incompatibility54
- Failure to Cut32
- Break9
- Material Twisted/Bent6
- Manufacturing, Packaging or Shipping Problem3
- Material Deformation2
- Crack1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- Insufficient Information29
TriLeap Lower Extremity Anatomic Plating System models
57 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TriLeap Lower Extremity Anatomic Plating System 3.0 mm Ti Variable Angle Screw Length 14 mm, Rose RedPlate, Fixation, Bone6 reports
- TriLeap Lower Extremity Anatomic Plating System 3.0 mm Ti Variable Angle Screw Length 18 mm, Rose RedPlate, Fixation, Bone6 reports
- 4 reports
- 4 reports
- 4 reports
- 4 reports
- TriLeap Lower Extremity Anatomic Plating System Small Ratchet Handle w/ Quick CouplingOrthopedic Manual Surgical Instrument4 reports
- TriLeap Lower Extremity Anatomic Plating System Lapidus Ti Plate 0 mm Step, RightPlate, Fixation, Bone4 reports
- 3 reports
- 3 reports
- 3 reports
- 2 reports
- 2 reports
- TriLeap Lower Extremity Anatomic Plating System MTP Screw Targeting Guide LeftGuide, Surgical, Instrument2 reports
- TriLeap Lower Extremity Anatomic Plating System Jewelers Cap Handle w/ Quick CouplingOrthopedic Manual Surgical Instrument2 reports
- TriLeap Lower Extremity Anatomic Plating System 2.0 mm Ti Variable Angle Screw Length 15 mm, BlueScrew, Fixation, Bone2 reports
- TriLeap Lower Extremity Anatomic Plating System 3.0 mm Ti Variable Angle Screw Length 12 mm, Rose RedPlate, Fixation, Bone2 reports
- TriLeap Lower Extremity Anatomic Plating System 3.5 mm Ti Variable Angle Screw Length 12 mm, Dark PurplePlate, Fixation, Bone2 reports
- TriLeap Lower Extremity Anatomic Plating System 1st MTP Ti Fusion Plate, Small, 5 Deg, RightPlate, Fixation, Bone2 reports
- 2 reports
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- TriLeap Lower Extremity Anatomic Plating System MTP Screw Targeting Guide RightGuide, Surgical, Instrument1 report
- 1 report
- 1 report
- 1 report
- 1 report
- TriLeap Lower Extremity Anatomic Plating System 2.0 mm Ti Variable Angle Screw Length 18 mm, BluePlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 2.5 mm Ti Cortex Screw Length 22 mm, MagentaPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 2.5 mm Ti Variable Angle Screw Length 16 mm, MagentaPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 2.5 mm Ti Variable Angle Screw Length 20 mm, MagentaPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 2.5 mm Ti Variable Angle Screw Length 26 mm, MagentaPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 2.5 mm Ti Variable Angle Screw Length 30 mm, MagentaPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 2.5 mm Ti Variable Angle Screw Length 32 mm, MagentaPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 2.5 mm Ti Variable Angle Screw Length 34 mm, MagentaPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 3.0 mm Ti Cortex Screw Length 14 mm, Rose RedPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 3.0 mm Ti Variable Angle Screw Length 16 mm, Rose RedPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 3.0 mm Ti Variable Angle Screw Length 26 mm, Rose RedPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 3.5 mm Ti Cortex Screw Length 16 mm, Dark PurplePlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 3.5 mm Ti Variable Angle Screw Length 14 mm, Dark PurplePlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 3.5 mm Ti Variable Angle Screw Length 16 mm, Dark PurplePlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 3.5 mm Ti Variable Angle Screw Length 18 mm, Dark PurplePlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 4.0 mm Ti Variable Angle Screw Length 22 mm, GreenPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 1st MTP Ti Fusion Plate, Small, 0 Deg, LeftScrew, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 1st MTP Ti Fusion Plate, Small, 0 Deg, RightScrew, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System Lapidus Ti Plate 0 mm Step, LeftPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System NC Ti Fusion 5 hole, Short, RightPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System NC Ti Fusion 5 hole, Long, RightPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System Cuboid W Ti Plate, StandardPlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System Compression Wire 1.6mm for 3.0/3.5/4.0 Plates, Thread Length 20mmOrthopedic Manual Surgical Instrument1 report
- TriLeap Lower Extremity Anatomic Plating System Compression Wire 1.6mm for 2.0/2.5/3.0 Plates, Thread Length 20mmOrthopedic Manual Surgical Instrument1 report
- TriLeap Lower Extremity Anatomic Plating System 2.0 Straight Ti Fracture Plate, 6 HolePlate, Fixation, Bone1 report
- TriLeap Lower Extremity Anatomic Plating System 2.0 Straight Ti Fracture Plate, 7 HolePlate, Fixation, Bone1 report
Recent TriLeap Lower Extremity Anatomic Plating System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break; Material Deformation
It was reported during an intra-operative procedure that COMP WIRE F/ 3.0/3.5/4.0 PL THREAD 20MM was used. While two 20 mm olive wires were being used to compress a TriLeap plate, one wire bent between the cone and the ball of the olive wire and then broke below the cone, flush with the bone. The surgeon changed the surgical plan and used two crossing screws instead. There was no reported patient harm, but the procedure was prolonged by 5 to 10 minutes. The allegation was limited to the wire, and the broken wire remained in the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858785 ↗MalfunctionSep 22, 2026Break
It was reported that a compression wire from the the Trileap Universal fracture set broke while taking it out. The wire broke below the compression ball, where the threads start. The device was discarded. There was no reported patient or user harm. There was no significant delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855186 ↗MalfunctionMay 27, 2026Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2026, 3.0 POLYAXIAL LOCKING SCREWS DID NOT LOCK INTO THE MPJ FUSION PLATE ITEM. THE SURGEON USED THE 2.0MM DRILL BIT THROUGH THE CONE OFF AXES BUT WITHIN THE LIMITS OF FREEDOM THE CONE GUIDE PROVIDES. WE WASTED TWO SCREWS THAT WILL NEED TO BE REPLACED. THERE WAS 5 MINUTES SURGICAL DELAY. SURGEON TRIED NEW LOCKING SCREW AT SAME SIZE. THAT DID NOT WORK THEN WE HAD TO SIZE UP TO A 3.5MM SCREW. THERE WAS PATIENT CONSEQUENCES. THERE WAS GOOD CLINICAL OUTCOME BUT HUGE DELAY IN CASE TIME COMPARED TO NORMAL FLOW, HUGE CONVERSION OPPORTUNITY POTENTIALLY LOST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302336 ↗MalfunctionMay 27, 2026Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2026, 3.0 POLYAXIAL LOCKING SCREWS DID NOT LOCK INTO THE MPJ FUSION PLATE ITEM. THE SURGEON USED THE 2.0MM DRILL BIT THROUGH THE CONE OFF AXES BUT WITHIN THE LIMITS OF FREEDOM THE CONE GUIDE PROVIDES. WE WASTED TWO SCREWS THAT WILL NEED TO BE REPLACED. THERE WAS 5 MINUTES SURGICAL DELAY. SURGEON TRIED NEW LOCKING SCREW AT SAME SIZE. THAT DID NOT WORK THEN WE HAD TO SIZE UP TO A 3.5MM SCREW. THERE WAS PATIENT CONSEQUENCES. THERE WAS GOOD CLINICAL OUTCOME BUT HUGE DELAY IN CASE TIME COMPARED TO NORMAL FLOW, HUGE CONVERSION OPPORTUNITY POTENTIALLY LOST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302324 ↗MalfunctionMay 27, 2026Device-Device Incompatibility
IT WAS REPORTED THAT 3.0MM TI VA SCR 18MM TRILEAP(TM) AND UNK - PLATES: TRAUMA WERE INVOLVED IN A REPORTED EVENT. DURING AN INTRAOPERATIVE PROCEDURE, THE TRILEAP 3.0 VA LOCKING SCREW WOULD NOT LOCK INTO THE TRILEAP MTP PLATE AT THE PROXIMAL MEDIAL LOCKING HOLE OF THE LEFT-SIDED PLATE. ATTEMPTS TO RESOLVE THE ISSUE BY DRILLING THE NEAR CORTEX WITH A 3.0 OVERDRILL WERE UNSUCCESSFUL, AND THE SURGEON ULTIMATELY USED A 3.5 CORTICAL SCREW INSTEAD. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE, AND NO OBSERVABLE CLINICAL SYMPTOMS OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301860 ↗MalfunctionMar 13, 2026Failure to Cut
IT WAS REPORTED THAT THE REAMERS ARE NOT SHARP AND TAKES A LOT TO REAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24591054 ↗MalfunctionMar 13, 2026Failure to Cut
IT WAS REPORTED THAT THE REAMERS ARE NOT SHARP AND TAKES A LOT TO REAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24591046 ↗MalfunctionMar 12, 2026Failure to Cut
IT WAS REPORTED ON AN UNKNOWN DATE THE REAMERS INSIDE THE TRILEAP SET WERE NOT SHARP AND TOOK A LOT TO REAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24586689 ↗MalfunctionMar 12, 2026Failure to Cut
IT WAS REPORTED THAT THE REAMERS ARE NOT SHARP AND TAKES A LOT TO REAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583306 ↗MalfunctionMar 12, 2026Failure to Cut
IT WAS REPORTED ON AN UNKNOWN DATE THE REAMERS INSIDE THE TRILEAP SET WERE NOT SHARP AND TOOK A LOT TO REAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24582636 ↗MalfunctionMar 12, 2026Failure to Cut
IT WAS REPORTED ON AN UNKNOWN DATE THE REAMERS INSIDE THE TRILEAP SET WERE NOT SHARP AND TOOK A LOT TO REAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24582635 ↗MalfunctionMar 12, 2026Failure to Cut
IT WAS REPORTED ON AN UNKNOWN DATE THE REAMERS INSIDE THE TRILEAP SET WERE NOT SHARP AND TOOK A LOT TO REAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24582628 ↗MalfunctionMar 12, 2026Failure to Cut
ADDITIONAL INFORMATION RECEIVED: WHAT IS THE TIMING OF THE REPORTED EVENT? POST-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24582619 ↗MalfunctionMar 12, 2026Failure to Cut
IT WAS REPORTED ON AN UNKNOWN DATE THE REAMERS INSIDE THE TRILEAP SET WERE NOT SHARP AND TOOK A LOT TO REAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24582593 ↗MalfunctionMar 12, 2026Failure to Cut
IT WAS REPORTED THAT THE REAMERS ARE NOT SHARP AND TAKES A LOT TO REAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24582326 ↗
Other Crossroads Extremity Systems products
All Crossroads Extremity Systems devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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