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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10013
Device Problem Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 09/17/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, during the planning stage in a cori assisted surgery, there was a problem with the screen flickering. The real intelligence 24 in. Touch screen flickering occurred when change in size/position of implant during planning stage. Also, during femur burring stage there was an overcut of the femoral condyle. The real intelligence robotic drill disconnected error continuously popped on screen. It is unknown how the procedure was completed and if there was any delay. The patient outcome is unknown.
 
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Brand NameREAL INTELLIGENCE ROBOTIC DRILL
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
austin, TX 78735
5123913905
MDR Report Key12561107
MDR Text Key274221945
Report Number3010266064-2021-00695
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K201022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10013
Device Catalogue NumberROB10013
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2022
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 Unkown

Patient Treatment Data
Date Received: 10/01/2021 Patient Sequence Number: 1
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