FREEDOM Residual Limb Lengthening SystemRecalls & reported problems across all models

We found 2 models of FREEDOM Residual Limb Lengthening System by Nuvasive Specialized Orthopedics, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between May 9, 2023 and May 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

FREEDOM Residual Limb Lengthening System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 29, 2021Open, Classified

   The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

   Z-0319-2022 · Root cause: Device Design · Recall details · FDA record ↗

2. Feb 12, 2021Open, Classified

   Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

   Z-1351-2021 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported FREEDOM Residual Limb Lengthening System problems

FREEDOM Residual Limb Lengthening System models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FREEDOM Residual Limb Lengthening System R14-100A130

  Rod, Fixation, Intramedullary And Accessories
  2 recalls1 report
• FREEDOM Residual Limb Lengthening System RLL1-000

  Rod, Fixation, Intramedullary And Accessories
  1 recall0 reports

Recent FREEDOM Residual Limb Lengthening System adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16897402 ↗

Other Nuvasive Specialized Orthopedics, Inc. products

• MAGEC Spinal Bracing and Distraction System29 models · 663 reports · 1 recall
• PRECICE Intramedullary Limb Lengthening System551 models · 177 reports · 4 recalls
• PRECICE STRYDE System231 models · 139 reports · 2 recalls
• PRECICE Bone Transport System561 models · 28 reports · 3 recalls
• PRECICE Plating System67 models · 24 reports · 3 recalls
• PRECICE Trauma Nail System182 models · 4 reports · 3 recalls
• Precice38 models · 9 reports · 1 recall
• PRECICE System15 models · 0 reports · 1 recall