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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
Catalog Number 6000-011-000
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2019
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility, the device's tip was found to be bent.A bent tip can lead to inaccuracies during a procedure.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during a procedure at the user facility, the device's tip was found to be bent.A bent tip can lead to inaccuracies during a procedure.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 Key8395370
MDR Text Key137992325
Report Number0001811755-2019-00733
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 03/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6000-011-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2019
Date Manufacturer Received03/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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