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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO BONE PIN STEROTAXIC INSTRUMENT, COMPUTER ASSISTED

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BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO BONE PIN STEROTAXIC INSTRUMENT, COMPUTER ASSISTED Back to Search Results
Catalog Number UNKNOWN
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 05/09/2018
Event Type  Injury  
Event Description
It was reported that the patient experienced a periprosthetic fracture through the proximal femoral navio pin site 43 days post-operatively. The fracture was fixed using a distal femoral periloc plate. No further complications have been reported.
 
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Brand NameNAVIO BONE PIN
Type of DeviceSTEROTAXIC INSTRUMENT, COMPUTER ASSISTED
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW
2905 northwest blvd.
suite 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 Key7580564
MDR Text Key110464853
Report Number3010266064-2018-00007
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,Followup
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/07/2020
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: 06/07/2018 Patient Sequence Number: 1
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