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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6000-011-000
Device Problems Material Fragmentation (1261); Deformation Due to Compressive Stress (2889)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 10/22/2019
Event Type  malfunction  
Event Description
It was observed the device had a broken tip, posing the risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Additional information added for d4, d10, h3, h4.Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was observed the device had a broken tip, posing the risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
LARGE POINTER
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9335744
MDR Text Key166953513
Report Number0001811755-2019-03776
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540245106
UDI-Public04546540245106
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 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6000-011-000
Device Catalogue Number6000-011-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2020
Date Manufacturer Received04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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