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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CRANIALMAP SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CRANIALMAP SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6000-660-000
Device Problems Unintended Application Program Shut Down (4032); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2021
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility there were multiple blue screens during a craniotomy case.The case was completed with a minor delay, but the images were inaccurate.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, to further clarify there was no inaccuracy identified.
 
Event Description
It was reported that during a procedure at the user facility there were multiple blue screens during a craniotomy case.The case was completed with a minor delay, but the images were inaccurate.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
CRANIALMAP SOFTWARE
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11871340
MDR Text Key252866223
Report Number3015967359-2021-00946
Device Sequence Number1
Product Code HAW
UDI-Device Identifier07613327327199
UDI-Public07613327327199
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 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6000-660-000
Device Catalogue Number6000-660-000
Device Lot NumberVERSION: UNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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