TRUE/LOK MONOLATERAL/BILATERAL FIXATOR 1 (REF 56-13655)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509858178), received between Jan 25, 2022 and Jan 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2022Break; Break

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DATE OF INITIAL SURGERY: UNIDENTIFIED. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA AND FOOT. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: FEMALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "PATIENT CAME TO CLINIC WITH A BROKEN 3/8 HEX RING, AT THE POINT NEXT TO THE JOINT. PATIENT HAS BEEN DOING 15,000 STEPS A DAY SO SURGEON THINKS THIS IS WHAT IT COULD BE DOWN TO. SAME PATIENT CAME TO CLINIC WITH BROKEN FOOTPLATE. FOOTPLATE WAS REMOVED AND PATIENT HAPPY." THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED: NOT SURE BUT PROBABLY THE SAME WEEK TO PUT ON NEW RING (AFTER 3/8 BROKE). A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED: JUST ROUTINE CLINIC VISITS. COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. COPY OF X-RAY IMAGES IS AVAILABLE. PATIENT'S CURRENT HEALTH CONDITION: FINE, SHOULD HAVE FRAME REMOVED SOON. F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13341736 ↗

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