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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOSENSOR 1855 GRIFFIN ROAD ORTHOSENSOR VERASENSE KNEE SYSTEM VERASENSE KNEE SYSTEM FOR JOURNEY II BCS

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ORTHOSENSOR 1855 GRIFFIN ROAD ORTHOSENSOR VERASENSE KNEE SYSTEM VERASENSE KNEE SYSTEM FOR JOURNEY II BCS Back to Search Results
Catalog Number SNN-JRNYBCS78-L
Device Problems Computer Software Problem (1112); Disconnection (1171)
Patient Problem No Information (3190)
Event Date 10/25/2016
Event Type  malfunction  
Event Description
Product was activated then properly transferred to sterile field. Device then disconnected from the receiver, and no longer transmitted data. This was discovered while attempting to zero the device. Although troubleshooting attempts were made, the device was never again able to transmit data, and so was not inserted in the patient. The device was returned to sponsor for reimbursement.
 
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Brand NameORTHOSENSOR VERASENSE KNEE SYSTEM
Type of DeviceVERASENSE KNEE SYSTEM FOR JOURNEY II BCS
Manufacturer (Section D)
ORTHOSENSOR 1855 GRIFFIN ROAD
ste a-310
dania beach FL 33004
MDR Report Key6092304
MDR Text Key59780009
Report NumberMW5065944
Device Sequence Number1
Product Code ONN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2017
Device Catalogue NumberSNN-JRNYBCS78-L
Device Lot Number051315V12704
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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