TriLeap Lower Extremity Anatomic Plating System MTP Screw Targeting Guide LeftRecalls & reported problems
Crossroads Extremity Systems · MTP Screw Targeting Guide Left · Class 1
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 00810112592412), received between May 2, 2025 and May 9, 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
- Defective Device1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED PRE-OPERATIVELY THAT, THE LEFT GUIDE WHERE THE MACHINED PORTION IS SUPPOSED TO FIT INTO THE SLOTTED HOLE IS TOO BIG AND DOESN¿T FIT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME.
Patient problems: Insufficient Information
MAUDE report 21997732 ↗MalfunctionMay 2, 2025Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE NEW TRILEAP MTP GUIDES WERE RECEIVED. WHILE TESTING BOTH RIGHT AND LEFT SIDED GUIDES WITH PLATES, IT WAS FOUND THAT THE RIGHT SIDED GUIDE ENGAGED AND FITTED WITH THE PLATES WITHOUT ISSUE. HOWEVER, THE LEFT SIDED GUIDE DID NOT FIT/ENGAGE INTO THE MTP PLATES. THE PRONG THAT WAS SUPPOSED TO CONNECT IN THE SLOTTED HOLE OF THE MTP PLATES SEEMED TOO LARGE TO FIT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21952340 ↗
Other Guide, Surgical, Instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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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