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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  Injury  
Event Description
It was reported that, during a cori assisted tka surgery, following the bone resection phase, the surgeon conducted a trial reduction with trial instruments and noticed the extension gap and flexion gaps were off.The issue of the incorrect bone resections according to the intra-operative plan could not be solved.To compensate, the surgeon used the cement mantle to align the femoral component into an acceptable position so that the achieved patients leg alignment was closer to the planned leg alignment.The surgeon only discovered after the procedure, when he printed off the patient report from the cori system, that an incorrect implant had been selected at the start of the procedure, a gii was selected instead of legion, and as he had planned to implant a legion knee he was under the impression he was planning and executing for a legion knee.This was the root cause of the issue.Patient's current health status is unknown.
 
Manufacturer Narrative
Internal complaint reference: case-(b)(4).
 
Manufacturer Narrative
H3, h6: the real intelligence cori, part number rob10024, used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.Cori is a surgical tool designed to provide assistance to the surgeon; it is not a substitute for the surgeon¿s experience and skill.The surgeon is responsible for implant planning and the conduct of the surgery during which cori is being used.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with the result of an incorrect implant selection.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
 
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Brand Name
REAL INTELLIGENCE CORI
Type of Device
ORTHOPEDIC 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 Key13938743
MDR Text Key288106843
Report Number3010266064-2022-00225
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556757420
UDI-Public00885556757420
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROB10024
Device Catalogue NumberROB10024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/08/2022
Initial Date FDA Received03/29/2022
Supplement Dates Manufacturer Received08/04/2022
Supplement Dates FDA Received08/10/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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