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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES UPS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES UPS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 200029
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2017
Event Type  Injury  
Event Description
It was reported that the case was not successful, it was not possible to start the navio. (battery was charged since yesterday) case was cancelled.
 
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Brand NameUPS
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
2905 northwest blvd ste 40
suite 100
plymouth, mn 
MDR Report Key9993932
MDR Text Key188838778
Report Number3010266064-2020-00538
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 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number200029
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/23/2020 Patient Sequence Number: 1
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