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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO THORACIC PEDICLE FEELER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO THORACIC PEDICLE FEELER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6002-350-000
Device Problem Bent (1059)
Patient Problem No Information (3190)
Event Date 03/24/2016
Event Type  malfunction  
Event Description
It was reported that the tip of the device was found to be bent at the user facility.Though requested, information was not available regarding patient involvement, medical interventions, delays, or adverse consequences.
 
Manufacturer Narrative
The reported event that the tip was bent was not confirmed.It was observed that the tip was broken off.Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.
 
Event Description
It was reported that the tip of the device was found to be bent at the user facility.Though requested, information was not available regarding patient involvement, medical interventions, delays, or adverse consequences.
 
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Brand Name
THORACIC PEDICLE FEELER
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-791 11
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5572983
MDR Text Key42499117
Report Number0001811755-2016-00371
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6002-350-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received05/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2014
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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