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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 Off-Label Use (1494); No Apparent Adverse Event (3189)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2020
Event Type  malfunction  
Event Description
It was reported that a box of flat markers had been used beyond its expiration date. The customer kept them on their shelf and obtained restock from the office. It was noticed during the setup of an ukr procedure, that the devices had expired in february 2020. This is the seventh of eight boxes used.
 
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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
richard confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
4126833844
MDR Report Key10228542
MDR Text Key197580105
Report Number3010266064-2020-01636
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model NumberPFSDV0016
Device Catalogue NumberPFSDV0016
Device Lot Number232106018
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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