FDA 483 - NuVasive Specialized Orthopedics, Inc. - May 06, 2024

NuVasive Specialized Orthopedics, Inc. received a Form 483 citing multiple deficiencies in its quality system related to the Precice Max System. Key issues include inadequate process validation, design control failures, insufficient risk analysis, and a failure to report device malfunctions. These deficiencies led to the distribution of numerous defective intramedullary fixation rods.