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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINTER, KNEE NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO POINTER, KNEE NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6003-011-000
Device Problems Fracture (1260); Material Fragmentation (1261)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 11/01/2019
Event Type  malfunction  
Event Description
The customer observed that a rubber gasket was missing on the device when inspected before a procedure.The gasket being detached poses the risk of a small component being lost in the surgical site.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.
 
Event Description
The customer observed that a rubber gasket was missing on the device when inspected before a procedure.The gasket being detached poses the risk of a small component being lost in the surgical site.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
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Brand Name
POINTER, KNEE NAVIGATION
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9386332
MDR Text Key168300652
Report Number0001811755-2019-03882
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540246028
UDI-Public04546540246028
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6003-011-000
Device Catalogue Number6003-011-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2020
Date Manufacturer Received05/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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