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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 Material Fragmentation (1261); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/21/2019
Event Type  malfunction  
Event Description
It was reported that during set up for a procedure the device was found stripped and broken.The device being fragmented 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 setup at the user 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
It was reported that during set up for a procedure the device was found stripped and broken.The device being fragmented 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 setup at the user facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 13 TO 20MM
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9331231
MDR Text Key166653116
Report Number0001811755-2019-03764
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540391926
UDI-Public04546540391926
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6000-999-004
Device Catalogue Number6000-999-004
Device Lot NumberC/10/2018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2019
Date Manufacturer Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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