FITBONE TAA SYSTEM 1 (REF 60001921)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18053340345347), received between Mar 18, 2025 and Apr 10, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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

• InjuryApr 10, 2025Mechanical Problem; Mechanical Problem

  RECEIVED INFORMATION STATING PATIENT WAS HOSPITALIZED DUE TO INCREASED PAIN POST LENGTHENING. AS PER REPORTED RADIOGRAPHIC INSPECTION IDENTIFIED EXCESSIVE ELONGATION. PATIENT HAS BEEN RELEASED FROM HOSPITAL. MANUFACTURER REF: (B)(4). DISTRIBUTOR REFERENCE: (B)(4).

  Patient problems: Implant Pain

  MAUDE report 21815001 ↗
• InjuryMar 18, 2025Break; Mechanical Problem; Break; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON'S NAME: (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2025; BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR; SURGERY DESCRIPTION: LENGTHENING; PATIENT INFORMATION: 13-YEAR-OLD, FEMALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; EVENT DESCRIPTION: THE NAIL CABLE STRETCHED AS IT PASSED THROUGH THE DEDICATED TUNNEL AND EVENTUALLY BROKE. THE NAIL WAS REMOVED AND REPLACED. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF ACHIEVED CORRECTION, THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS AVAILABLE TO COMPLETE SURGERY; THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 1 EXTRA HOUR. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. COPY OF X-RAY IMAGES IS NOT AVAILABLE. PATIENT'S CURRENT HEALTH CONDITION: NO CONSEQUENCES FOR THE PATIENT. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632826 ↗