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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 Problem Imprecision (1307)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 12/18/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was alleged by the user facility to the sales representative that during a versatile hip navigation procedure, the navigation device does not match the patient's actual outcome. The surgeon wanted to intentionally lengthen the operative leg by 3mm. Post operative x rays show the leg was actually lengthened by 8mm. The surgeon decided that no further revisions were necessary. There was no further medical intervention reported, or surgical delays.
 
Event Description
It was alleged by the user facility to the sales representative that during a versatile hip navigation procedure, the navigation device does not match the patient's actual outcome. The surgeon wanted to intentionally lengthen the operative leg by 3mm. Post operative x rays show the leg was actually lengthened by 8mm. The surgeon decided that no further revisions were necessary. There was no further medical intervention reported, or surgical delays.
 
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Brand NameORTHOMAP® VERSATILE HIP 2.0 SOFTWARE
Type of DeviceEAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7189298
MDR Text Key115209608
Report Number0001811755-2018-00052
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141551
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6007-616-000
Device Lot NumberVERSION 2.0-1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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