# FDA 483 - Medtronic Navigation, Inc.-Boxborough - June 11, 2024

Source: https://www.keypedia.com/records/483/medtronic-navigation-inc-boxborough/f91e4756-dec0-4a2e-95d1-596eee37f06c

> FDA 483 for Medtronic Navigation, Inc.-Boxborough on June 11, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Navigation, Inc.-Boxborough
- Inspection Date: 2024-06-11
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Medtronic Navigation, Inc.-Boxborough identified two significant compliance issues. The firm failed to submit Medical Device Reports (MDRs) within the required 30-day timeframe for several device malfunctions. Additionally, device history records for the O-Arm O2 Imaging System were not adequately maintained, lacking essential safety labeling.

## Related Documents

- [483 - 2018-01-03](https://www.keypedia.com/records/483/medtronic-navigation-inc-boxborough/05b55678-dd94-459b-9eab-c9260f65d46c)
- [483 - 2018-01-03](https://www.keypedia.com/records/483/medtronic-navigation-inc-boxborough/05dcd2b4-f338-4514-9acc-4e43ae7453a1)

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/medtronic-navigation-inc-boxborough/e864dd74-6f9e-4fc1-a677-017f22994700

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144