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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 Migration (4003)
Patient Problem Injury (2348)
Event Date 05/08/2019
Event Type  Injury  
Event Description
It was reported that at the start of ukr case, had trouble collecting hip center due to the patient's bmi. Also had a very hard time collecting the last bar of the unstressed range of motion and collecting a point in the last third of the stressed range of motion. The lowest that could get on the hip center was 1. 4, so took that and moved forward. The patient's anatomy proved for a difficult gap planning too, especially due to flexion contracture and tightness in extension. The patient then drastically loosened towards terminal flexion. Moved into burring and the surgeon looked it was off the bone on the posterior femur, but took bone. Then moved to the tibia and finished that burring without incident. Then moved back to the femur, started with the anterior lug hole. Once it was blurred, saw that the hole was on the very edge of the medial condyle and surgeon decided to complete procedure with manual instrumentation.
 
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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 Key9994248
MDR Text Key188812336
Report Number3010266064-2020-01099
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
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 Received08/17/2020
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

Patient Treatment Data
Date Received: 04/24/2020 Patient Sequence Number: 1
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