TriLeap Lower Extremity Anatomic Plating System 3.0 mm Ti Variable Angle Screw Length 14 mm, Rose RedRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810112594317), received between Jan 3, 2025 and Nov 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON SEPTEMBER 26, 2025, LOCKING SCREWS DID NOT LOCK INTO THE PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526442 ↗
• MalfunctionJan 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS AN INTRAOPERATIVE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21265385 ↗
• MalfunctionJan 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP) - INTRA-OP. B. WAS THERE A PATIENT INVOLVEMENT? (YES OR NO): YES. C. PLEASE INDICATE THE EVENT DETAILS THAT ARE ASSOCIATED WITH TYBER MEDICAL¿S PRODUCT. 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. TRAINERS HAVE RECOMMENDED DRILLING THROUGH THE NEAR CORTEX SO THAT THE SCREW CAN SIT DOWN FAR ENOUGH, INDICATING A LARGE DESIGN FLAW. D. IS THERE ANY IMPLICATION TOWARDS THE DEVICE (04.354.222)? WAS THE ASSOCIATED DEVICE USED IN A LOCKING HOLE FOR FIXATION? YES. E. INTRA-OP: WAS THERE A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT? YES. F. WAS OTHER MEDICAL INTERVENTION REQUIRED? NO. G. ARE YOU ABLE TO CONFIRM IF THE 04.354.222 SCREW WAS USED TO FIXATE THE PLATE, OR IF IT WAS JUST USED AS AN ACCESSORY IN THE SURGERY? FIXATE PLATE.

  Patient problems: Insufficient Information

  MAUDE report 21070411 ↗
• 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 21070401 ↗
• 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 21070400 ↗
• 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 21070388 ↗