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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 Problem No Patient Involvement (2645)
Event Date 06/29/2019
Event Type  malfunction  
Event Description
It was reported the device was in pieces during a routine maintenance visit this poses the 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 testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
 
Event Description
It was reported the device was in pieces during a routine maintenance visit this poses the 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 testing 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.H3 other text : discarded.
 
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Brand Name
NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 20 TO 27MM
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8826342
MDR Text Key152191408
Report Number0001811755-2019-02559
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540391933
UDI-Public04546540391933
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6000-999-005
Device Catalogue Number6000-999-005
Device Lot NumberA/05/2018
Was Device Available for Evaluation? No
Date Manufacturer Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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