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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO FLAT MARKERS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO FLAT MARKERS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number PFSDV0016
Device Problems Material Twisted/Bent (2981); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2022
Event Type  Injury  
Event Description
It was reported that, during a cori assisted tka surgery, the real intelligence femur tracker was blinking in and out of camera view despite the camera was looking directly at it. Also, an excessive amount of writing was noticed on the reflective surface of the flat marker; therefore, they swapped the noted flat marker out, but it did not help. The procedure was resumed, after a non-significant delay, by changing to manual procedure. No patient complications were reported. Moreover, the real intelligence femur tracker appears to be bent.
 
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Brand NameNAVIO FLAT MARKERS
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 Key14342729
MDR Text Key291276268
Report Number3010266064-2022-00351
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201022
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 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPFSDV0016
Device Catalogue NumberPFSDV0016
Device Lot Number22BK00194
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/09/2022 Patient Sequence Number: 1
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