Truelok System 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18033509853821), received between Nov 12, 2019 and May 12, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Break

  RECEIVED INFORMATION THAT ALLEGED AN OLIVE WIRE INSERTED TO FOOT, SNAPPED DURING TREATMENT. PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REVISE THE FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147570 ↗
• MalfunctionOct 14, 2020Break

  INFORMATION PROVIDED STATES THAT ON (B)(6) 2020 THE PATIENT HAD A TRUELOK FRAME PLACED ON RIGHT FOOT. THE PATIENT RETURNED TO CLINIC APPROXIMATELY 3 WEEK AFTER SURGERY FOR POST-OP FOLLOW-UP. IT WAS NOTICED AT THAT TIME THAT 2 PINS HAD BROKEN. A REVISION SURGERY WAS PERFORMED TO REPLACE THE PINS. ALL PIECES OF THE PINS WERE SUCCESSFULLY REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10677081 ↗
• InjuryNov 12, 2019Break

  INFORMATION PROVIDED STATES THAT ON (B)(6) 2019 THE PATIENT HAD A TRUELOK FRAME PLACED ON RIGHT FOOT AND ANKLE. THE PATIENT RETURNED TO CLINIC APPROXIMATELY 2 WEEKS AFTER SURGERY FOR POST OP FOLLOW-UP. IT WAS NOTICED AT THAT TIME THAT A STRUT AND TWO PINS HAD BROKEN. A REVISION SURGERY WAS PERFORMED TO REPLACE THE PINS AND STRUT. ALL PIECES OF THE PINS WERE SUCCESSFULLY REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9312523 ↗