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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SPHERES ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES SPHERES ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 100563
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2015
Event Type  Injury  
Event Description
It was reported that during case the image of the bur tip over the color coded image of the cut surface was shaking while cutting. This resulted in an altered cut plan. The post holes were slightly off from where they should have been. This was using the smith and nephew implant. Doctor went in and manually adjusted the placement of the peg holes by approximately 1 mm to get the desired placement. The femur was cut first. About 75% of the femur was cut in exposure control and then the last 25% was cut in manual control. The image was shaking during all of the femur cutting. The shaking stopped as soon as the case advanced to refine tibia. No shaking was experienced during the tibia stage of the case.
 
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Brand NameSPHERES
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd
ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest
blvd ste 40
plymouth, mn
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
MDR Report Key9994090
MDR Text Key188846247
Report Number3010266064-2020-00254
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number100563
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 Received08/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/23/2020 Patient Sequence Number: 1
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