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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 2 TO 7MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 2 TO 7MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6000-999-002
Device Problems Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/13/2019
Event Type  malfunction  
Event Description
It was reported that, during testing, it was observed that the locking mechanism is missing; 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
Additional information added for d4, d10, h3, h4 device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that, during testing, it was observed that the locking mechanism is missing; 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.
 
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Brand Name
NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 2 TO 7MM
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8741571
MDR Text Key149424261
Report Number0001811755-2019-02157
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540391902
UDI-Public04546540391902
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 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6000-999-002
Device Catalogue Number6000-999-002
Device Lot NumberC/01/2014
Was Device Available for Evaluation? No
Date Manufacturer Received11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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