FITBONE TAA SYSTEM 1 (REF 60001383)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18053340343930), received between Nov 28, 2024 and Dec 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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.

• InjuryDec 8, 2024Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6), SURGEON'S NAME: (B)(6), PRODUCT CODE: 60001445, BATCH NUMBER: 6217512, DATE OF INITIAL SURGERY: ON (B)(6) 2023, APPLICATION SITE: RIGHT TIBIA, SURGERY DESCRIPTION: CORRECTION AND LENGTHENING, PATIENT INFORMATION: 45 YEARS, MALE, 98 KG, 186 CM, STATUS POST SPINA BIFIDA OCCULTA, PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE, EVENT DESCRIPTION: "NAIL BREAKAGE, ACKNOWLEDGED AT FOLLOW UP EXAMINATION; LOSS OF CORRECTION + PAIN; REQUIRED SURGICAL INTERVENTION." THE REPORTING FORM ALSO INDICATED: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS ON PATIENT: LOSS OF ACHIEVED CORRECTION. AN ADDITIONAL SURGERY WAS REQUIRED PERFORMED ON (B)(6) 2024. COPY OF THE OPERATIVE REPORTS IS AVAILABLE (NOT RECEIVED BY ORTHOFIX). COPY OF X-RAY IMAGES IS AVAILABLE. PATIENT CURRENT HEALTH CONDITION: PATIENT RECOVERING WELL; CORRECTION RESTORED + FITBONE EXCHANGED TO TRAUMA NAIL. FURTHER INFORMATION RECEIVED ON DECEMBER 3, 2024: THE NAIL BREAKAGE WAS DUE TO WRONG WEIGHT BEARING OF THE PATIENT AND NOT DUE TO A TECHNICAL PROBLEM OF THE NAIL. THE SURGEON USED A TRAUMA NAIL TO RECOVER THE CORRECTION. THE PATIENT IS DOING WELL,

  Patient problems: Loss of fracture reduction

  MAUDE report 20875180 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFORMATION PROVIDED BY THE HOSPITAL INVOLVED INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6). PRODUCT CODE: 60001383. BATCH NUMBER: B4636190. APPLICATION SITE: FEMUR. PATIENT INFORMATION: MALE. PATIENT NUMBER: (B)(6). DATE OF SURGERY: (B)(6) 2024. SURGERY DESCRIPTION: LENGTHENING. DATE OF EVENT ONSET: 21-NOV-2024. DATE OF EVENT AWARENESS: (B)(6) 2024, ADMISSION TO OUR EMERGENCY DEPARTMENT. EVENT DESCRIPTION: "LEFT FEMUR FRACTURE (ABOVE THE LENGTHENING NAIL) FOLLOWING A MECHANICAL FALL - SLIDE IN A SHOPPING MALL. THE NAIL DID NOT BREAK BUT THERE IS A LINK WITH THE LOCATION OF THE FEMORAL FRACTURE". THE REPORTING FORM ALSO INDICATED: COPY OF X-RAY IMAGES IS AVAILABLE. PATIENT CURRENT HEALTH CONDITION: HOSPITALIZATION IN THE PEDIATRICS SURGERY DEPARTMENT - SURGERY PLANNED ON THE (B)(6) 2024. ON (B)(6) 2025, ORTHOFIX RECEIVED A COPY OF THE COMPLETED COMPLAINT FORM WHICH INCLUDES THE FOLLOWING ADDITIONAL DETAILS: PATIENT'S INFORMATION: 15 YEARS, MALE, WITH WEAK BONE DENSITY DURING THE RE-INTERVENTION PERFORMED ON (B)(6) 2024, A PLATE WAS ADDED OVER THE NAIL. THE NAIL WAS NOT REMOVED. BONE CONSOLIDATION IS GOING WELL, PATIENT IS OK. ORTHOFIX SRL REF: (B)(4). DISTRIBUTOR REF

  Patient problems: Loss of fracture reduction

  MAUDE report 20804046 ↗