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

Source: https://www.globalkeysolutions.net/records/483/nuvasive-specialized-orthopedics-inc/6ffe4943-4d03-46cc-980a-e429c9ee6cf5

> FDA 483 for NuVasive Specialized Orthopedics, Inc. on May 06, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NuVasive Specialized Orthopedics, Inc.
- Inspection Date: 2024-05-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [Kevin N. Tran](https://www.globalkeysolutions.net/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.globalkeysolutions.net/companies/nuvasive-specialized-orthopedics-inc/e6b230f0-aa1f-4d11-8596-16b91bbdafca

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6