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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM KOREA ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM KOREA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number ROB00079
Device Problem Application Program Problem: Parameter Calculation Error (1449)
Patient Problems Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  Injury  
Event Description
It was reported that after navio tka procedure while viewing post-op x-ray, the implant presented severe valgus, despite navio said it was 0 degrees on post-op gap assessment. When reviewing the log files, something weird was found with collecting med/lat malleoli points. With case visualizer, lateral malleoli point in right next to tibial centre. It seemed the mechanical axis had collected totally wrong way. They tried to recreate the same situation of the case, but navio does not allow user to proceed with collecting wrong malleoli points. A warning kept appearing on neutral position collection step with wrong malleoli points.
 
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Brand NameNAVIO SURGICAL SYSTEM KOREA
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11617632
MDR Text Key243903276
Report Number3010266064-2021-00264
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberROB00079
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/06/2021 Patient Sequence Number: 1
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