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 Problems Image Display Error/Artifact (1304); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2018
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the siemens 3d orbic images could not be correlated.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Event Description
It was reported that during a procedure at the user facility the siemens 3d orbic images could not be correlated.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
After additional information from the customer, the reported event was further clarified to reflect that the malfunction was not related to image correlation.The reported event was related to a loss of system function of the device due to the workflow not being followed.The interruption of the workflow of the device and software application being used for the procedure would not allow the initialization of correlation, therefore lack of accuracy due to correlation would not be possible.As this event does not relate to a correlation inaccuracy, it is not likely to contribute to or cause a serious injury and was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify a mdr was not required for this event.
 
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 Key7882850
MDR Text Key120528175
Report Number0001811755-2018-01656
Device Sequence Number1
Product Code HAW
UDI-Device Identifier07613327004175
UDI-Public07613327004175
Combination Product (y/n)N
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number7700-800-000
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-