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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NGENIUS TIBIA TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO NGENIUS TIBIA TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6003-024-000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 02/19/2014
Event Type  malfunction  
Event Description
It was reported that the interface of the ngenius tibia tracker was loose during routine preventative maintenance at the user facility, which has the potential to cause accuracy issues if not noticed by the user during a procedure.There was no patient involvement and no adverse consequences associated with the device.
 
Event Description
It was reported that the interface of the ngenius tibia tracker was loose during routine preventative maintenance at the user facility, which has the potential to cause accuracy issues if not noticed by the user during a procedure.There was no patient involvement and no adverse consequences associated with the device.
 
Manufacturer Narrative
During failure analysis, the reported event that the interface of the tracker was loose was confirmed by the complaint engineer.During the visual inspection, the grey cap was found to be loose.The device was discarded by the manufacturer following evaluation.
 
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Brand Name
NGENIUS TIBIA TRACKER
Type of Device
NEUROLOGICAL 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-79 111
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3686190
MDR Text Key4239508
Report Number0001811755-2014-00929
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6003-024-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received07/17/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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