TRUE/LOK MONOLATERAL/BILATERAL FIXATOR 1 (REF 56-11650)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18033509857218), received between Mar 16, 2018 and Mar 16, 2018 — 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.

• InjuryMar 16, 2018Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2017; BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR; SURGERY DESCRIPTION: CORRECTION; PATIENT'S INFORMATION: (B)(6), FEMALE; PROBLEM OBSERVED DURING: DURING TREATMENT; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: "THERE IS NO KNOWN REASON FOR THE BREAKAGE OF THE RING. THE PATIENT ARRIVED TO THE HOSPITAL INFORMING THAT THE RING BROKE DURING DAILY ACTIVITIES, NORMALLY PERFORMED FROM THE DAY OF THE INITIAL SURGERY. DURING THE MEDICAL EXAMINATION, SHE DID NOT REPORT PAIN OR OTHER EFFECTS ON THE AFFECTED LIMB. THE RADIOGRAPHIC CONTROL DID NOT EVIDENCE CHANGES IN THE CONSOLIDATION OF THE CALLUS." 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 DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: AS OF TODAY IT SEEMS NOT NECESSARY A PROLONGATION OF TREATMENT, AN ADDITIONAL SURGERY WAS REQUIRED: IT WAS PERFORMED ON (B)(6) 2018, A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED, CO

  Patient problems: No Code Available

  MAUDE report 7344346 ↗

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