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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CAMERA, POLARIS SPECTRA ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES CAMERA, POLARIS SPECTRA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 200027
Device Problems Display or Visual Feedback Problem (1184); Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2018
Event Type  malfunction  
Event Description
It was reported that during the equipment verification the camera showed bump light on and the message on the screen said "camera infrared lamp is not working properly. This may result in limited range of view". The surgeon continued the procedure but during the implant planning step he found the varus/valgus values and the extension/flexion values were all not normal. As a result, he decided to convert to manual procedure. No patient injury was reported. Investigation confirmed there was an illuminator hardware fault.
 
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Brand NameCAMERA, POLARIS SPECTRA
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9994403
MDR Text Key188805116
Report Number3010266064-2020-00558
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/13/2020
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 Number200027
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
Was Device Evaluated by Manufacturer? Yes
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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