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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNIVERSAL TRACKER EM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO UNIVERSAL TRACKER EM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 01 046 02
Device Problems Image Display Error/Artifact (1304); Incorrect Measurement (1383)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2019
Event Type  malfunction  
Event Description
It was reported that the navigation of the universal tracker was inaccurate during a procedure.The possible harm associated with a reported event of inaccuracy during a procedure is a revision surgery.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
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that the navigation of the universal tracker was inaccurate during a procedure.The possible harm associated with a reported event of inaccuracy during a procedure is a revision surgery.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
UNIVERSAL TRACKER EM
Type of Device
EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9153451
MDR Text Key161451047
Report Number0001811755-2019-03156
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/08/2020
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 Catalogue Number01 046 02
Device Lot Number180145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2019
Initial Date Manufacturer Received 09/09/2019
Initial Date FDA Received10/03/2019
Supplement Dates Manufacturer Received01/08/2020
Supplement Dates FDA Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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