TRUE/LOK MONOLATERAL/BILATERAL FIXATOR 1 (REF 54-1139)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 18033509856563), received between Jul 2, 2024 and Dec 4, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K941048); they may or may not involve this specific model.

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.

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.

• MalfunctionDec 4, 2025Mechanical Problem; Mechanical Problem

  RECEIVED INFORMATION STATING THAT USER EXPERIENCED TENSION ISSUES ON TWO TENSIONERS DURING SURGERY OF A FRACTURED TIBIA. AS PER REPORTER SURGICAL PROCEDURE WAS DELAYED BY APPROXIMATELY 60 MINUTES. THE PATIENT IS REPORTED AS BEING IN RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714659 ↗
• MalfunctionDec 4, 2025Mechanical Problem; Mechanical Problem

  RECEIVED INFORMATION STATING THAT USER EXPERIENCED TENSION ISSUES ON TWO TENSIONERS DURING SURGERY OF A FRACTURED TIBIA. AS PER REPORTER SURGICAL PROCEDURE WAS DELAYED BY APPROXIMATELY 60 MINUTES. THE PATIENT IS REPORTED AS BEING IN RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714593 ↗
• MalfunctionOct 11, 2024Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2024. - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. - SURGERY DESCRIPTION: PILON FX -EX FIX APPLICATION. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PATIENT INFORMATION: 49-YEAR-OLD, FEMALE. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: NEITHER WIRE TENSIONERS IN INSTRUMENT SET TENSIONED WIRES. THEY WERE NEW TENSIONERS, BUT THEY WERE. IMPOSSIBLE TO SQUEEZE. WIRES WILL NEED TO BE REPLACED AND PROPERLY TENSIONED IN AN ADDITIONAL SURGERY. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF FRACTURE REDUCTION. - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. - A REPLACEMENT DEVICE WAS NOT AVAILABLE TO COMPLETE SURGERY: WIRES WERE LEFT LOOSE. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 40 MINUTES. - AN ADDITIONAL SURGERY IS REQUIRED: TO BE DEFINED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429861 ↗
• MalfunctionOct 11, 2024Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6), SURGEON'S NAME: DR.(B)(6), DATE OF INITIAL SURGERY: ON (B)(6)2024, BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA, SURGERY DESCRIPTION: PILON FX -EX FIX APPLICATION, SURGERY DESCRIPTION: FRACTURE TREATMENT, PATIENT INFORMATION: 49-YEAR-OLD, FEMALE, PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: NEITHER WIRE TENSIONERS IN INSTRUMENT SET TENSIONED WIRES. THEY WERE NEW TENSIONERS, BUT THEY WERE IMPOSSIBLE TO SQUEEZE. WIRES WILL NEED TO BE REPLACED AND PROPERLY TENSIONED IN AN ADDITIONAL SURGERY. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF FRACTURE REDUCTION THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE A REPLACEMENT DEVICE WAS NOT AVAILABLE TO COMPLETE SURGERY: WIRES WERE LEFT LOOSE THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 40 MINUTES AN ADDITIONAL SURGERY IS REQUIRED: TO BE DEFINED A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE COPIES OF THE X-RAY IMAGES ARE AVAILABLE (NOT REC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427086 ↗
• MalfunctionJul 2, 2024Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED STATES: HOSPITAL NAME: (B)(6) HOSPITAL SURGEON'S NAME: DR.(B)(6). DATE OF INITIAL SURGERY: UNKNOWN. BODY PART TO WHICH DEVICE WAS APPLIED: UNKNOWN. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: N/A. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: THE TENSIONERS PART NUMBER 54- 1139 X 2 WOULD NOT TENSION DURING THE SURGERY. THE TERRITORY MANAGER STATES THAT THERE WAS ABOUT AN HOUR DELAY IN THE SURGERY BUT NO AFFECT ON THE PATIENT. THEY WERE ABLE TO COMPLETE THE SURGERY WITHOUT FURTHER ISSUES. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: ABOUT AN HOUR. AN ADDITIONAL SURGERY IS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: UNKNOWN. PLEASE ALSO REFER TO MFR REPORT 2183449-2024-00008.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657822 ↗
• MalfunctionJul 2, 2024Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED STATES: - HOSPITAL NAME: (B)(6) - SURGEON'S NAME: (B)(6) - DATE OF INITIAL SURGERY: UNKNOWN - BODY PART TO WHICH DEVICE WAS APPLIED: UNKNOWN - SURGERY DESCRIPTION: CORRECTION - PATIENT INFORMATION: N/A - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: THE TENSIONERS PART NUMBER 54- 1139 X 2 WOULD NOT TENSION DURING THE SURGERY. THE TERRITORY MANAGER STATES THAT THERE WAS ABOUT AN HOUR DELAY IN THE SURGERY BUT NO AFFECT ON THE PATIENT. THEY WERE ABLE TO COMPLETE THE SURGERY WITHOUTH FUTHER ISSUES. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: ABOUT AN HOUR - AN ADDITIONAL SURGERY IS NOT REQUIRED - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE - PATIENT CURRENT HEALTH CONDITION: UNKNOWN PLEASE ALSO REFER TO MFR REPORT 2183449-2024-00009.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K941048. One submission often covers many models, so check the product and lot details in each record.

• Z-0674-2008 · Sep 28, 2007 · Terminated
  Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150m