• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM KOREA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number ROB00079
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Loss of Range of Motion (2032); Deformity/ Disfigurement (2360)
Event Date 06/10/2020
Event Type  Injury  
Event Description
It was reported that after a ukr procedure with navio, the surgeon was complaining that the x-ray did not seem posterior slope as tibial baseplate was anteriorly sloped. However, on the system log, the slope was for 7 degree for posterior. The patient is unable to reach full extension.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
suite 100
austin, TX 78735
5123913905
MDR Report Key10228429
MDR Text Key197542825
Report Number3010266064-2020-01628
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberROB00079
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2022
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 Reuse

Patient Treatment Data
Date Received: 07/03/2020 Patient Sequence Number: 1
-
-