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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINE TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINE TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6002-005-000
Medical Device Problem Code Intermittent Communication Failure (4038)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/07/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility the device was inaccurate.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 during a procedure at the user facility the device was 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
SPINE TRACKER
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11738764
Report Number3015967359-2021-00731
Device Sequence Number14251299
Product Code HAW
UDI-Device Identifier04546540350176
UDI-Public04546540350176
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/12/2021
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 Model Number6002-005-000
Device Catalogue Number6002-005-000
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 04/07/2021
Supplement Date Received by Manufacturer08/11/2021
Initial Report FDA Received Date04/28/2021
Supplement Report FDA Received Date08/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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