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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SEEKER, RH FRONTAL SINUS; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO SEEKER, RH FRONTAL SINUS; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6001-032-000
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2015
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the healthcare facility, the tip of the rh frontal sinus seeker was bent.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.Additional information has been requested from the healthcare facility.
 
Event Description
It was reported that during a surgical procedure at the healthcare facility, the tip of the rh frontal sinus seeker was bent.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.Additional information has been requested from the healthcare facility.
 
Manufacturer Narrative
During the device evaluation, the reported event was confirmed, however, a root cause for the breakage could not be determined.The device was not returned to the healthcare facility, as it was not repairable.
 
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Brand Name
SEEKER, RH FRONTAL SINUS
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 Key4489843
MDR Text Key5346882
Report Number0001811755-2015-00398
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002732
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 01/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6001-032-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/25/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2009
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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