FITBONE TAA SYSTEM 1 (REF 60001404)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 18053340343947), received between Jun 11, 2025 and Sep 15, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Mechanical Problem

  Received information that alleged the Fitbone nail implanted on femur on (b)(6) 2026, stopped lengthening during treatment.Patient underwent a revision procedure on (b)(6) 2026 to replace the nail.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767217 ↗
• InjuryMay 25, 2026Mechanical Jam

  RECEIVED INFORMATION THAT ALLEGED THE FITBONE NAIL IMPLANTED ON LEFT LEG ON (B)(6) 2026, DID NOT LENGTHEN. THE NAIL WAS IMPLANTED AND TESTED. AS PER THE REPORTER AFTER REACHING THE 4.3 CM LENGTHENING, THE NAIL STOPPED WORKING. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO REPLACE THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270445 ↗
• InjuryApr 9, 2026Electrical /Electronic Property Problem; Mechanical Problem

  AS PER REPORTER, DURING TREATMENT FOR RIGHT FEMUR LENGTHENING, THE FITBONE NAIL STOPPED LENGTHENING. AS PER REPORTER THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO ADD AN EXTERNAL FIXATOR AND CONTINUE WITH LENGTHENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24825651 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED INFORMATION STATING ANTICIPATED PRODUCT WAS NOT DELIVERED, SURGERY PROCEEDED WITH A 35-MINUTE DELAY. AS PER THE REPORTER, NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603040 ↗
• MalfunctionOct 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT FITBONE NAIL DID NOT DISTRACT DURING SURGICAL PROCEDURE. THE NAIL WAS REPLACED CAUSING A 30 MINUTE SURGICAL DELAY. AS PER REPORTER PATIENT IS DOING WELL. DISTRIBUTOR REF: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321203 ↗
• InjuryJun 11, 2025Break; Break

  AS PER REPORTER, THE CABLE WAS SEVERED FROM THE NAIL DURING THE SURGICAL PROCEDURE CAUSING A 3 HOUR SURGICAL DELAY. THE SURGERY WAS FINALIZED SUCCESSFULLY WITH A REPLACEMENT NAIL. NO PATIENT HARM WAS NOTED. DISTRIBUTOR REF: BETHEL-KRANKENHAUS. ORTHOFIX SRL REF: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182175 ↗