TRUE/LOK MONOLATERAL/BILATERAL FIXATOR 1 (REF 54-1152)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509853760), received between Aug 11, 2020 and Aug 11, 2020 — 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.

• InjuryAug 11, 2020Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: OTHER, SEE EVENT DESCRIPTION. PATIENT INFORMATION: MALE, (B)(6)KG, WITH INFECTION. PROBLEM OBSERVED DURING: OTHER, SEE EVENT DESCRIPTION. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THE SURGERY WAS DONE BECAUSE THE PATIENT HAD A PLATE PLACED ON A FRACTURE WHICH GOT INFECTED. THE SURGERY WENT WELL. WHILE THE PATIENT WAS ASLEEP IN HIS BED, ONE OF THE BOLT OF THE TRUELOK BROKE. PATIENT WILL BE REOPERATED TO STRENGTHEN THE CONSTRUCT AGAIN ON (B)(6) 2020". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION). 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: SCHEDULED ON (B)(6) 2020. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. THE EVENT SHOULD BE NOTIFIED TO THE LOCAL COMPETENT AUTHORITY. INF

  Patient problems: No Code Available

  MAUDE report 10390699 ↗

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