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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10024
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  Injury  
Event Description
It was reported that a patient with a significant pre-operative varus alignment of 14 degrees underwent into a cori assisted tka surgery. The surgeon chose to adjust both the femur and tibia in 3 degrees of varus, making for a combined 6 degree varus post-operative alignment. For execution, the surgeon did a distal burr bone removal with the cori robot, placed his manual jii cut block, and checked the anterior cut slot for accuracy prior to cutting the femur. Then, used the visualize cut screen to place the manual tibia cut block to match the planned resections to less than a degree deviation from the plan, and cut the tibia with a saw blade. The surgeon did not make any additional soft tissue releases. During trialing, at the post-operative baseline screen, the leg alignment showed 10 degrees of varus, 4 more than what the surgeon had planned for. The post-operative x ray appears that the tibia baseplate is in excessive varus, ~ 7-8 degrees based off of the templating on the x ray. The patient was not harmed beyond the reported problem.
 
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
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Brand NameREAL INTELLIGENCE CORI
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 Key13047259
MDR Text Key283158101
Report Number3010266064-2021-00888
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROB10024
Device Catalogue NumberROB10024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2021
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

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