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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STRYKER Q GUIDANCE SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STRYKER Q GUIDANCE SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 8900-100-000
Device Problems Display or Visual Feedback Problem (1184); Incorrect Measurement (1383); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2023
Event Type  malfunction  
Event Description
Per the customer, auto-segmentation was not available after the airo scan as the licensing for it was not implemented.While navigating screws, there appeared to be movement on the screen/images without anything touching the screen.After a confirmation spin with the airo, 2 out of 8 screws were angled more cranial despite following our preplanned trajectory.The two screws were revised after the confirmation scan.The procedure was completed successfully with the same device without a clinically significant delay; no medical intervention or adverse consequences were reported.
 
Event Description
Per the customer, auto-segmentation was not available after the airo scan as the licensing for it was not implemented.While navigating screws, there appeared to be movement on the screen/images without anything touching the screen.After a confirmation spin with the airo, 2 out of 8 screws were angled more cranial despite following our preplanned trajectory.The two screws were revised after the confirmation scan.The procedure was completed successfully with the same device without a clinically significant delay; no medical intervention or adverse consequences were reported.
 
Manufacturer Narrative
Follow-up report submitted to document the device was not available for evaluation.No product return.
 
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Brand Name
STRYKER Q GUIDANCE SYSTEM
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
GM   D-79111
Manufacturer Contact
colette chung
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key16444838
MDR Text Key310273238
Report Number3015967359-2023-00487
Device Sequence Number1
Product Code HAW
UDI-Device Identifier07613327503265
UDI-Public07613327503265
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8900-100-000
Device Catalogue Number8900-100-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexMale
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