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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVIGATED MIS JIG - A; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO NAVIGATED MIS JIG - A; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6003-200-010
Device Problem Component Missing (2306)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 10/18/2019
Event Type  malfunction  
Event Description
During inspection at the customer facility, it was visually observed that the device fell apart and screws were missing.No medical intervention and no adverse consequences were reported with this event.As this event occurred during inspection at the customer facility, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
During inspection at the customer facility, it was visually observed that the device fell apart and screws were missing.No medical intervention and no adverse consequences were reported with this event.As this event occurred during inspection at the customer facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
NAVIGATED MIS JIG - A
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
DE   D-79111
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key9318718
MDR Text Key166428339
Report Number0001811755-2019-03750
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540470348
UDI-Public04546540470348
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6003-200-010
Device Catalogue Number6003-200-010
Device Lot Number2010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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