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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 20 TO 27MM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 20 TO 27MM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6000-999-005
Device Problems Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 02/28/2020
Event Type  malfunction  
Event Description
It was reported that in the central sterile department of the user facility, the thumb knob was found missing. No medical intervention and no adverse consequences were reported with this event. As this event occurred during sterile processing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand NameNAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 20 TO 27MM
Type of DeviceNEUROLOGICAL 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
D-79111
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key9861290
MDR Text Key184327951
Report Number0001811755-2020-00740
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6000-999-005
Device Catalogue Number6000-999-005
Device Lot NumberA/09/2018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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