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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES UNKNOWN NAVIO DEVICE ORTHOPEDIC STEREOTAXIC INSTRUMENT
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BLUE BELT TECHNOLOGIES UNKNOWN NAVIO DEVICE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Cellulitis (1768); Unspecified Infection (1930)
Event Date 01/01/1901
Event Type  Injury  
Event Description
"predictors of extended length of stay after unicompartmental knee arthroplasty". Author: b. M. Sephton et al. , 2019. The purpose of the study was to identify factors that independently predict extended length of stay after unicompartmental knee arthroplasty (uka) surgery (defined as length of stay longer than 3 days), and to identify factors predicting early post-operative complications. One of the patients that was operated with robotic (navio) technique had cellulitis, which was settled with antibiotics.
 
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Brand NameUNKNOWN NAVIO DEVICE
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 Key10109185
MDR Text Key193324460
Report Number3010266064-2020-01589
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUK
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 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
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: 06/02/2020 Patient Sequence Number: 1
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