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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM UK ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number ROB00049
Device Problem Application Program Problem: Parameter Calculation Error (1449)
Patient Problems Injury (2348); Deformity/ Disfigurement (2360)
Event Date 09/29/2020
Event Type  Injury  
Event Description
It was reported that, after a navio procedure, the tibia was noticed in excessive varus and femur in valgus. It seems like there has been a mal-positioning of the components potentially due to incorrect malleolus collection. No other complications have been reported. It is unknown if a revision surgery will be performed in the future to correct the problem.
 
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Brand NameNAVIO SURGICAL SYSTEM UK
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 Key10701776
MDR Text Key212064648
Report Number3010266064-2020-01896
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K191223
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 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberROB00049
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/09/2018
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: 10/19/2020 Patient Sequence Number: 1
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