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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMALL POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO SMALL POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6000-012-000
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Date 12/09/2013
Event Type  malfunction  
Event Description
It was reported by the stryker sales representative that the tip of the small pointer was found to be bent while checking his sample inventory.There was no patient involvement and no adverse consequences associated with the device.
 
Manufacturer Narrative
Device not yet received for investigation.
 
Event Description
It was reported by the stryker sales representative that the tip of the small pointer was found to be bent while checking his sample inventory.There was no patient involvement and no adverse consequences associated with the device.
 
Manufacturer Narrative
The reported event that the pointer tip was bent was duplicated; it was confirmed that the device had a bent tip and could not be validated.It is possible that bending forces caused the reported event.The device was repaired and put back into stryker stock.
 
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Brand Name
SMALL POINTER
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 Key3549935
MDR Text Key15118674
Report Number0001811755-2014-00012
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993239
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 12/09/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6000-012-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/21/2014
Initial Date FDA Received01/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/20/2014
Was Device Evaluated by Manufacturer? No
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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