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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 11/09/2017
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 surgeon wanted to intentionally lengthen the operative leg by 1cm in order to achieve length equality on both sides. After securing final implants, the navigation final reduction displayed 10mm long as intended. Post operatively, the patient was actually lengthened by 2. 5cm. The surgeon had to perform a revision surgery to shorten the leg by 1. 5cm. There was no further medical intervention reported, or surgical delays due to the revision.
 
Event Description
It was alleged by the user facility to the sales representative that during a versatile hip navigation procedure, the surgeon wanted to intentionally lengthen the operative leg by 1cm in order to achieve length equality on both sides. After securing final implants, the navigation final reduction displayed 10mm long as intended. Post operatively, the patient was actually lengthened by 2. 5cm. The surgeon had to perform a revision surgery to shorten the leg by 1. 5cm. There was no further medical intervention reported, or surgical delays due to the revision.
 
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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 Key7085209
MDR Text Key192073834
Report Number0001811755-2017-02402
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2017
Is this an Adverse Event Report? Yes
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 Received02/15/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/05/2017 Patient Sequence Number: 1
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