TrueLok Evo 1Recalls & reported problems
Orthofix Srl · TRUELOK EVO RX STRUT LONG WITH DYNA STERILE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18052469472071), received between May 14, 2024 and May 14, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem3
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE TLEVO LONG STRUTS WITH DYNA BROKE ABOVE DYNAMIZER AND PATIENT NEEDED TO HAVE A REMOVAL SURGERY. DATE OF REMOVAL IS UNKNOWN. BREAKAGE WAS REALIZED IN A FOLLOW UP APPOINTMENT ON (B)(6) 2024. DATE OF REMOVAL HAS BEEN REQUESTED. PLEASE REFERENCE MFR REPORTS 2183449-2024-00002 AND 2183449-2024-00003.
Patient problems: Failure of Implant
MAUDE report 19313049 ↗InjuryMay 14, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE TLEVO LONG STRUTS WITH DYNA BROKE ABOVE DYNAMIZER AND PATIENT NEEDED TO HAVE A REMOVAL SURGERY. DATE OF REMOVAL IS UNKNOWN. BREAKAGE WAS REALIZED IN A FOLLOW UP APPOINTMENT ON (B)(6) 2024. DATE OF REMOVAL HAS BEEN REQUESTED. PLEASE REFERNECE MFR REPORTS 2183449-2024-00002 AND 2183449-2024-00004
Patient problems: Failure of Implant
MAUDE report 19313001 ↗InjuryMay 14, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE TLEVO LONG STRUTS WITH DYNA BROKE ABOVE DYNAMIZER AND PATIENT NEEDED TO HAVE A REMOVAL SURGERY. DATE OF REMOVAL IS UNKNOWN.BREAKAGE WAS REALIZED IN A FOLLOW UP APPOINTMENT ON (B)(6) 2024. DATE OF REMOVAL HAS BEEN REQUESTED. PLEASE REFERNECE MFR REPORTS 2183449-2024-00003 AND 2183449-2024-00004.
Patient problems: Failure of Implant
MAUDE report 19312006 ↗
Other Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite devices
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- LOCK SCREW SQUARE DRIVE 131827120Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE1 recall0 reports
- IJS IJS-E Base Plate AssemblySkeletal Dynamics L.L.C. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE28 reports
- NA 390.008Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE21 reports
- NA 294.56Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 390.003Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 394.85Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- TRUE/LOK MONOLATERAL/BILATERAL FIXATOR 1Orthofix Srl · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite6 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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