Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER NAV3I(TM) PLATFORM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-KALAMAZOO STRYKER NAV3I(TM) PLATFORM; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 7700-800-000
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2019
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility, there was an issue with visibility of the device's tracker hand piece, and losing accuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during a procedure at the user facility, there was an issue with visibility of the device's tracker hand piece, and losing accuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STRYKER NAV3I(TM) PLATFORM
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8428058
MDR Text Key139053508
Report Number0001811755-2019-00840
Device Sequence Number1
Product Code HAW
UDI-Device Identifier07613327004175
UDI-Public07613327004175
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number7700-800-000
Device Lot Number51265
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2019
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-