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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO CHECKPOINT VERIFICATION PINS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO CHECKPOINT VERIFICATION PINS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number PFSD01009
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/13/2020
Event Type  Injury  
Event Description
It was reported that, when checking the x-rays the following day after a navio ukr procedure, it was noted that two verification check pins had been left in the patient. This report is for the second pin. Both pins were removed three days post-operation.
 
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Brand NameNAVIO CHECKPOINT VERIFICATION PINS
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 Key10935895
MDR Text Key219314057
Report Number3010266064-2020-02085
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPFSD01009
Device Catalogue NumberPFSD01009
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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