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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES UNKN NAVIO ROBOTICS DEV ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES UNKN NAVIO ROBOTICS DEV ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number UNKN06100500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of Range of Motion (2032)
Event Date 01/21/2021
Event Type  Injury  
Event Description
On the literature article named "initial experience with the navio robotic-assisted total knee replacement-coronal alignment accuracy and the learning curve. ", it was reported that, after using the navio robotic-assisted system for tkr with legion prosthesis, 2 patients underwent an unspecified manipulation under anesthesia due to stiffness at 6 weeks postoperatively. The outcome of the patients is unknown.
 
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Brand NameUNKN NAVIO ROBOTICS DEV
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 Key12142914
MDR Text Key260711867
Report Number3010266064-2021-00536
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKN06100500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/09/2021 Patient Sequence Number: 1
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