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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SMALL ACTIVE FRAME NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SMALL ACTIVE FRAME NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9733886
Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
Patient information not provided due to japanese patient privacy regulations. No parts have been received by the manufacturer for evaluation. Act. Part not returned for analysis.
 
Event Description
A site representative reported that, while in a spinal fusion, a led on the reference frame could not be recognized by the navigation system. The surgeon opted to complete the procedure without the use of the navigation system. There was no reported delay to the procedure due to this issue. There was no impact on patient outcome. No additional information was provided.
 
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Brand NameSMALL ACTIVE FRAME
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7102845
MDR Text Key94410254
Report Number1723170-2017-05059
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00763000055134
UDI-Public00763000055134
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 12/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9733886
Device Lot Number110708
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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