MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER NAV3(R) PLATFORM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	7700-700-000
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the navigation system was unable to load images correctly during preparation for a cranial procedure.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that the navigation system was unable to load images correctly during preparation for a cranial procedure.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: STRYKER NAV3(R) PLATFORM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8544461
• Report Number: 0001811755-2019-01299
• Device Sequence Number: 2458059
• Product Code: HAW
• UDI-Device Identifier: 04546540696427
• UDI-Public: 04546540696427
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 7700-700-000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1