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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AWL; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO AWL; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6002-700-000
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/25/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility a piece came off the device.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Event or Problem Description
It was reported that during a procedure at the user facility a piece came off the device.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.
 
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Brand Name
AWL
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8444598
Report Number0001811755-2019-00921
Device Sequence Number2926760
Product Code HAW
UDI-Device Identifier04546540387448
UDI-Public04546540387448
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
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) 05/20/2019
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 Number6002-700-000
Device Lot Number10477
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2019
Initial Date Received by Manufacturer 02/25/2019
Supplement Date Received by Manufacturer05/20/2019
Initial Report FDA Received Date03/22/2019
Supplement Report FDA Received Date05/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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