TriLeap Lower Extremity Anatomic Plating System 3.0 mm Ti Variable Angle Screw Length 18 mm, Rose RedRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810112594331), received between Jan 29, 2025 and May 27, 2026 — 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.

• 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 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE DOCTOR WAS IMPLANTING A TRILEAP 2ND/3RD TMT PLATE. THE DOCTOR DRILLED FOR A 3.0 TRILEAP SCREW; A DRILL GUIDE WASN'T USED. THE DOCTOR THEN DETERMINED TO USE A LOCKING SCREW. AN 18MM, 3.0 LOCKING SCREW WAS INSERTED, BUT DIDN'T LOCK INTO THE PLATE. DOCTOR THOUGHT A THREAD POTENTIALLY STRIPPED OFF THE SCREW. PER TECHNIQUE WITH A 3.0 LOCKING SCREW, DOCTOR PROCEEDED WITH DRILLING THE NEAR CORTEX WITH THE 3.5MM LAG BIT TO PREPARE THE NEAR CORTEX TO ASSIST THE SCREW WITH SEATING. A NEW 18MM, 3.0 LOCKING SCREW WAS SELECTED TO BE IMPLANTED. THIS SCREW DIDN'T LOCK INTO THE PLATE EITHER. IT COULDN'T BE DETERMINED WHETHER THE LOCKING HOLE WAS DAMAGED OR IF THE SHOULDER OF THE 3.0 LOCKING SCREWS PROHIBITED THE SCREW FROM PROPERLY SEATING INTO THE LOCKING HOLE IN THE PLATE. DOCTOR THEN CHOSE TO IMPLANT A 3.5 CORTEX SCREW, WHICH WAS SUCCESSFULLY IMPLANTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A MINIMAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21565014 ↗
• MalfunctionMar 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE DOCTOR WAS IMPLANTING A TRILEAP 2ND/3RD TMT PLATE. THE DOCTOR DRILLED FOR A 3.0 TRILEAP SCREW; A DRILL GUIDE WASN'T USED. THE DOCTOR THEN DETERMINED TO USE A LOCKING SCREW. AN 18MM, 3.0 LOCKING SCREW WAS INSERTED, BUT DIDN'T LOCK INTO THE PLATE. DOCTOR THOUGHT A THREAD POTENTIALLY STRIPPED OFF THE SCREW. PER TECHNIQUE WITH A 3.0 LOCKING SCREW, DOCTOR PROCEEDED WITH DRILLING THE NEAR CORTEX WITH THE 3.5MM LAG BIT TO PREPARE THE NEAR CORTEX TO ASSIST THE SCREW WITH SEATING. A NEW 18MM, 3.0 LOCKING SCREW WAS SELECTED TO BE IMPLANTED. THIS SCREW DIDN'T LOCK INTO THE PLATE EITHER. IT COULDN'T BE DETERMINED WHETHER THE LOCKING HOLE WAS DAMAGED OR IF THE SHOULDER OF THE 3.0 LOCKING SCREWS PROHIBITED THE SCREW FROM PROPERLY SEATING INTO THE LOCKING HOLE IN THE PLATE. DOCTOR THEN CHOSE TO IMPLANT A 3.5 CORTEX SCREW, WHICH WAS SUCCESSFULLY IMPLANTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A MINIMAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21565005 ↗
• MalfunctionJan 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING SCREWS WOULD NOT ENGAGE THE PLATE DESPITE ATTEMPTS MADE TO TROUBLESHOOT THE ISSUE. THE PHYSICIAN BECAME FRUSTRATED WITH THE TRILEAP LOCKING SYSTEM AND ELECTED TO USE A LEGACY VA FOOT MTP PLATE INSTEAD. THE TRIPLEAD PLATE IS AVAILABLE FOR RETURN WITH THIS COMPLAINT THE SCREWS ARE NOT.

  Patient problems: Insufficient Information

  MAUDE report 21265418 ↗