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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM BE/FR/DE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM BE/FR/DE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 71420574
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Synovitis (2094); Inadequate Osseointegration (2646)
Event Date 06/24/2020
Event Type  Injury  
Event Description
It was reported that, after a navio-assisted pfa had been performed on the right side, the patient experienced synovitis and pain. The adverse event was treated with arthroscopic synovectomy; in such surgery, the patella was found to be damaged and probably caused synovitis to the unstable patellofemoral component. The patient is able to mobilise post-operatively.
 
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Brand NameNAVIO SURGICAL SYSTEM BE/FR/DE
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
austin, TX 78735
5123913905
MDR Report Key10431956
MDR Text Key203693733
Report Number3010266064-2020-01722
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeBE
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 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71420574
Device Catalogue NumberNPFS02020
Device Lot NumberUNKNOWN
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 Received09/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/20/2020 Patient Sequence Number: 1
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