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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number NPFS02000
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2019
Event Type  malfunction  
Event Description
It was reported that during ukr case, doctor moved from planning to tibia cutting to start the case. After moving back to the femur, the system was showing the handpiece going beyond the bone model when in reality it wasn't. The recon rep tried checking the checkpoints, but they were correct. After moving the femur a click in planning and recalibrating, doctor was able to continue with the case without incident. Delay of more than 30 minutes was reported.
 
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Brand NameNAVIO SURGICAL SYSTEM US
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2828 liberty ave
suite 100
pittsburgh, pa
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9994251
MDR Text Key189768047
Report Number3010266064-2020-01094
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
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

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