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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 01/13/2014
Event Type  malfunction  
Event Description
The ngenius tibia tracker was returned to stryker instruments freiburg for service, and during functional evaluation it was noted that the interface of the device was not rigid.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 device was not rigid was confirmed by the service technician.During the visual inspection, it was found that the tracker interface was loose and that the blue cap was also loose.The device was discarded by the manufacturer following evaluation.
 
Event Description
The ngenius tibia tracker was returned to stryker instruments freiburg for service, and during functional evaluation it was noted that the interface of the device was not rigid.There was no patient involvement and no adverse consequences associated with the device.
 
Manufacturer Narrative
Failure analysis is ongoing; additional information may be submitted once the results analysis is complete.
 
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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 Key3619085
MDR Text Key4636003
Report Number0001811755-2014-00412
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 01/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2014
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 Manufacturer01/17/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received07/18/2014
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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