FITBONE® TAA1140-F-205Recalls & reported problems
WITTENSTEIN intens GmbH · Intramedullary lengthening nail · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260170143938), received between Feb 12, 2021 and Feb 12, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (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
Device problems
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2021Therapeutic or Diagnostic Output Failure
INFORMATION PROVIDED STATES THAT THE PATIENT HAD A FITBONE NAIL IMPLANTED IN THE FEMUR ON (B)(6) 2020. IT WAS NOTICED DURING A POST-OP VISIT ON (B)(6) 2021 THAT THERE WAS NO LENGTHENING OF THE NAIL. THE DISTRIBUTOR REPRESENTATIVE TESTED THE NAIL FOR DISTRACTION ON (B)(6) 2021 USING A 2ND CONTROL UNIT. THE NAIL FAILED TO LENGTHEN WITH THE NEW CONTROL UNIT. A REVISION SURGERY WILL BE SCHEDULED TO FURTHER PATIENT'S TREATMENT.
Patient problems: Insufficient Information
MAUDE report 11325533 ↗
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- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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