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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. N/A ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. N/A ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733236
Device Problem Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 09/22/2020
Event Type  malfunction  
Event Description
Medtronic navigation screwdriver allegedly bent during a surgical procedure.
 
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Brand NameN/A
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC.
826 coal creek cir
louisville CO 80027
MDR Report Key12646764
MDR Text Key276918834
Report Number12646764
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733236
Device Catalogue Number9733236
Device Lot Number2019110399
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/01/2021
Event Location Hospital
Date Report to Manufacturer10/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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