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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVIGATED MIS JIG - B; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO NAVIGATED MIS JIG - B; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6003-200-020
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility a measuring piece broke off.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.
 
Event Description
It was reported that during a procedure at the user facility a measuring piece broke off.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
NAVIGATED MIS JIG - B
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
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7654656
MDR Text Key112867578
Report Number0001811755-2018-01123
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540470355
UDI-Public04546540470355
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6003-200-020
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2008
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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