Medtronic Navigation, Inc.-BoxboroughJune 11, 2024

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

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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.

Company: Medtronic Navigation, Inc.-Boxborough
Inspection Date: June 11, 2024
Product Type: Device
Office: New England District Office
Person: Nabil Nakhoul

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ID · f91e4756-dec0-4a2e-95d1-596eee37f06c