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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO THORACIC PEDICLE FEELER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO THORACIC PEDICLE FEELER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6002-350-000
Device Problems Image Display Error/Artifact (1304); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 10/07/2019
Event Type  malfunction  
Event Description
It was reported that it was observed during a procedure the tip of the device was discovered to be loose; this poses the risk of inaccuracy and revision surgeries.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
 
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 reported that it was observed during a procedure the tip of the device was discovered to be loose; this poses the risk of inaccuracy and revision surgeries.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
 
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Brand Name
THORACIC PEDICLE FEELER
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9221268
MDR Text Key163228135
Report Number0001811755-2019-03299
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540503824
UDI-Public04546540503824
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number6002-350-000
Device Catalogue Number6002-350-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2020
Initial Date Manufacturer Received 10/08/2019
Initial Date FDA Received10/22/2019
Supplement Dates Manufacturer Received04/29/2020
Supplement Dates FDA Received04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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