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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 Problems Loss of Range of Motion (2032); Fibrosis (3167)
Event Date 05/06/2022
Event Type  Injury  
Event Description
It was reported that, after a cori assisted tka surgery had been performed on 17-mar- 2022, the patient had a range of motion of 80 degrees and it was not improving with therapy. The patient will undergo a manipulation under anesthesia on 10-may-2022 to treat this adverse event. The patient is recovering.
 
Manufacturer Narrative
Internal complaint reference: (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 Key14545156
MDR Text Key292957027
Report Number3010266064-2022-00416
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 Study,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2022
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 Received08/01/2022
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: 05/30/2022 Patient Sequence Number: 1
Treatment
JOURNEY TIBIA BASE NP LT SZ 6, LOT#:21HM11952; JRNY BCS PAT RESRF RD 35 MM STD, LOT#:21JM05301; JRNY II CR FEM COCR NP LT SZ 6, LOT#:B2124620; JRNY II CR ISRT XLPE LT SZ 5-6 10MM, LOT#19EM13116
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