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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES UNKNOWN CORI DEV ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES UNKNOWN CORI DEV ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 74013489
Device Problem Mechanical Jam (2983)
Patient Problem Injury (2348)
Event Date 07/23/2020
Event Type  Injury  
Event Description
It was reported that during a cori tka procedure, when using the 3. 2 mm x 110 mm speed pins on the tibia, the pin got stuck in the speed pin driver. They tried to separate the pin from the driver, but it remained stuck and completely pulled out of the tibia as he pulled on the drill. They switched to the 4. 0 x 127 mm bone pin for the tibia. They were able to resume without any issue.
 
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Brand NameUNKNOWN CORI DEV
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
rick confer
2828 liberty avenue
suite 100, PA 15222
4126833844
MDR Report Key10425642
MDR Text Key203502986
Report Number3010266064-2020-01718
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number74013489
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2021
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 Reuse

Patient Treatment Data
Date Received: 08/19/2020 Patient Sequence Number: 1
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