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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® PRECISION KNEE 5.0 SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® PRECISION KNEE 5.0 SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6003-655-000
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2019
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the software showed an inaccuracy of implant placement, while final x-rays were able to verify the implant placement was accurate.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Event Description
It was reported that during a procedure at the user facility the software showed an inaccuracy of implant placement, while final x-rays were able to verify the implant placement was accurate.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 the data log files were not available for inspection, no evaluation is possible.
 
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Brand Name
ORTHOMAP® PRECISION KNEE 5.0 SOFTWARE
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8357831
MDR Text Key136749217
Report Number0001811755-2019-00614
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540717443
UDI-Public04546540717443
Combination Product (y/n)N
PMA/PMN Number
K022579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6003-655-000
Device Lot NumberVERSION 5.0
Was Device Available for Evaluation? No
Date Manufacturer Received05/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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