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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007-616-000
Device Problems Image Display Error/Artifact (1304); Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2019
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the depth of the hip software was off.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 depth of the hip software was off.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE
Type of Device
EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8560138
MDR Text Key143394088
Report Number0001811755-2019-01556
Device Sequence Number1
Product Code PGW
UDI-Device Identifier07613327004250
UDI-Public07613327004250
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/12/2019
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 Number6007-616-000
Device Lot NumberVERSION 2.0-3
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/02/2019
Initial Date FDA Received04/29/2019
Supplement Dates Manufacturer Received11/12/2019
Supplement Dates FDA Received11/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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