FITBONE TAA SYSTEM 1 (REF 60001780)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 18053340344692), received between Mar 4, 2025 and Jun 9, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Electrical /Electronic Property 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.

• InjuryJun 9, 2026Electrical /Electronic Property Problem

  RECEIVED INFORMATION THAT ALLEGED THE FITBONE RECEIVER, IMPLANTED ON (B)(6) 2026, DID NOT LENGTHEN. THE RECEIVER WAS IMPLANTED AND TESTED. AS PER THE REPORTER ONE WEEK POSTOPERATIVELY LENGTHENING WAS NOT WORKING. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO REPLACE THE RECEIVER. NAIL IS LENGTHENING AS INTENDED AFTER RECEIVER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449602 ↗
• InjuryMay 12, 2026Electrical /Electronic Property Problem

  RECEIVED INFORMATION THAT ALLEGED THE FITBONE RECEIVER, IMPLANTED ON (B)(6) 2026, DID NOT LENGTHEN. THE RECEIVER WAS IMPLANTED AND TESTED. AS PER THE REPORTER ONE WEEK POSTOPERATIVELY LENGTHENING WAS NOT WORKING. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO REPLACE THE RECEIVER. NAIL IS LENGTHENING AS INTENDED AFTER RECEIVER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149734 ↗
• InjuryMay 12, 2026Electrical /Electronic Property Problem

  RECEIVED INFORMATION THAT ALLEGED THE FITBONE RECEIVER, IMPLANTED ON (B)(6) 2026, DID NOT LENGTHEN. THE RECEIVER WAS IMPLANTED AND TESTED. AS PER THE REPORTER ONE WEEK POSTOPERATIVELY LENGTHENING WAS NOT WORKING. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026 TO REPLACE THE RECEIVER. NAIL IS LENGTHENING AS INTENDED AFTER RECEIVER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25147093 ↗
• InjuryMar 26, 2026

  INTERNAL BONE TRANSPORT NAIL MOTOR FAILED HALFWAY THROUGH BONE TRANSPORT REQUIRING ADDITIONAL SURGERY, ADDITIONAL ANESTHESIA AND INCREASED RISK FOR INFECTION. REQUIRED TO REMOVE INTRAMEDULLARY NAIL AND PLACE NEW INTRAMEDULLARY NAIL. MULTIPLE CONSECUTIVE XRAYS CONFIRMED FAILURE OF BONE TRANSPORT NAIL MOVEMENT.

  Patient problems: Failure of Implant

  MAUDE report 24702055 ↗
• InjuryMay 7, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A FITBONE NAIL IMPLANTED ON (B)(6) 2025 DOES NOT FUNCTION. ON (B)(6) 2025 THE PATIENT UNDERWENT A REVISION PROCEDURE. AS PER THE REPORTED, THE PATIENT IS IN GOOD HEALTH CONDITION AND THE TREATMENT IS ONGOING.

  Patient problems: Failure of Implant

  MAUDE report 21974365 ↗
• InjuryMar 4, 2025Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) - SURGEON'S NAME: PROF. (B)(6). - PRODUCT CODE AND SERIAL NUMBER: UNIDENTIFIED - DATE OF INITIAL SURGERY: (B)(6) 2024 - APPLICATION SITE: FEMUR LEFT - SURGERY DESCRIPTION: HIP DISTALIZATION - PATIENT INFORMATION: 27-YEAR-OLD, FEMALE, 59 KG, 164 CM, PREVIOUS HEALTH CONDITION: HEALTHY - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE - EVENT DESCRIPTION: NO MOTOR FUNCTION. THE CABLE OF THE RECEIVER WRAPPED AROUND THE INTRAMEDULLARY NAIL, RESULTING IN A LOSS OF FUNCTION. THIS HAS TO DO WITH THE SPECIAL SURGICAL TECHNIQUE FOR HIP DISTALISATION AND IS NO PRIMARY MALFUNCTION OF THE FITBONE. THE REPORTING FORM ALSO INDICATED: - THE DEVICE FAILURE CAUSED ADVERSE EFFECTS ON PATIENT - 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: PERFORMED ON (B)(6) 2024 TO CHANGE THE NAIL - COPY OF X-RAY IMAGES IS AVAILABLE - PATIENT CURRENT HEALTH CONDITION: PROBLEM BASED ON THE CONNECTING DEVICE. NO PROBLEM WITH FITBONE. THE TREATMENT WAS SUCCESSFULLY FINISHED. DISTRIBUTOR REF: MAY 2024 MUNICH ORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514865 ↗