TRUE/LOK MONOLATERAL/BILATERAL FIXATOR 1 (REF 56-10930)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18033509857041), received between May 6, 2021 and May 6, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 56-10930 (TL PLUS FULL RING, 160MM). BATCH NUMBERS: 1708267 AND 1903624 (MFR REPORTS 9680825-2021-00038 AND 9680825-2021-00039 RESPECTIVELY). QUANTITY: 1 EACH. DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT LEG. SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: 24 YEARS, MALE, 80 KG, 175 CM IN GOOD HEALTH CONDITION. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "NA 8° SEMANA DE TRATAMENTO APÓS JÁ TER FEITO O ALONGAMENTO O PACIENTE OUVIU UM ESTALO AO CAMINHAR EM CASA E PERCEBEU QUE UM DOS ANÉIS HAVIA QUEBRADO E O OUTRO TRINCADO. PACIENTE FOI SUBMETIDO A UMA REVISÃO PARA TROCA DOS ANÉIS QUEBRADOS - IN THE 8TH WEEK OF TREATMENT, AT THE END OF THE LENGTHENING, THE PATIENT HEARD A CRACK WHEN WALKING AT HOME AND REALIZED THAT ONE OF THE RINGS HAD BROKEN AND THE OTHER ONE CRACKED. THE PATIENT UNDERWENT A REVIEW TO REPLACE THE BROKEN RINGS.". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. T

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11782441 ↗
• InjuryMay 6, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 56-10930 (TL PLUS FULL RING, 160MM), BATCH NUMBERS: 1708267 AND 1903624 (MFR REPORTS 9680825-2021-00039 RESPECTIVELY), QUANTITY: (B)(4), DATE OF INITIAL SURGERY: (B)(6) 2020, BODY PART TO WHICH DEVICE WAS APPLIED: LEFT LEG, SURGERY DESCRIPTION: CORRECTION, PATIENT'S INFORMATION: (B)(6) YEARS, MALE, (B)(6) KG, 175 CM IN GOOD HEALTH CONDITION, PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: "NA 8¿ SEMANA DE TRATAMENTO AP¿S J¿ TER FEITO O ALONGAMENTO O PACIENTE OUVIU UM ESTALO AO CAMINHAR EM CASA E PERCEBEU QUE UM DOS AN¿IS HAVIA QUEBRADO E O OUTRO TRINCADO. PACIENTE FOI SUBMETIDO A UMA REVIS¿O PARA TROCA DOS AN¿IS QUEBRADOS - IN THE 8TH WEEK OF TREATMENT, AT THE END OF THE LENGTHENING, THE PATIENT HEARD A CRACK WHEN WALKING AT HOME AND REALIZED THAT ONE OF THE RINGS HAD BROKEN AND THE OTHER ONE CRACKED. THE PATIENT UNDERWENT A REVIEW TO REPLACE THE BROKEN RINGS". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11782440 ↗

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