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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 13 TO 20MM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 13 TO 20MM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6000-999-004
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 02/11/2020
Event Type  malfunction  
Event Description
It was reported that during preventative maintenance the device's screw was found missing. The screw missing poses a risk of a small component being lost in the surgical site. No medical intervention and no adverse consequences were reported with this event. As this event occurred during preventative maintenance at the user 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 13 TO 20MM
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 Key9774906
MDR Text Key181580369
Report Number0001811755-2020-00599
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 Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6000-999-004
Device Catalogue Number6000-999-004
Device Lot NumberA/02/2018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2020
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 Manufactured02/09/2018
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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