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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. NAVLOCK UNIVERSAL GREY TRACKER ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. NAVLOCK UNIVERSAL GREY TRACKER ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734590
Device Problems Break (1069); Separation Problem (4043)
Patient Problem Insufficient Information (4580)
Event Date 08/09/2021
Event Type  malfunction  
Event Description
When instruments sent down to be terminally cleaned, spd (sterile processing department) noticed a piece of one of the medtronic navlock grey trackers was missing. Case was already finished, and we could not determine if broken before case, during case, or after. Nsm called surgeon and notified him of the missing piece. Doctor said he would review x-rays taken during and at end of case to look for any broken metal pieces. He did so and texted nsm back that he did not see any. Went to place for msi additional x-ray and surgeon did not want them done at this time because "moving the patient may cause a durotomy" and he will make sure to order the necessary x-ray when it is safe to move the patient and before she.
 
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Brand NameNAVLOCK UNIVERSAL GREY TRACKER
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC.
826 coal creek cir
louisville CO 80027
MDR Report Key12597994
MDR Text Key275422845
Report Number12597994
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 09/13/2021,08/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734590
Device Lot Number181016
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/13/2021
Event Location No Information
Date Report to Manufacturer10/08/2021
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?
Type of Device Usage Unkown

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