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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS, ULNAR STEM, SMALL, RIGHT, 70MM

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TORNIER INC. LATITUDE ELBOW PROSTHESIS, ULNAR STEM, SMALL, RIGHT, 70MM Back to Search Results
Catalog Number 0030020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/28/2016
Event Type  Injury  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event Description
It was reported that the implanted latitude was removed from the patient's right shoulder due to infection. A new device was placed. No further patient complications have been reported.
 
Event Description
It was reported that the implanted latitude was removed from the patient's right elbow due to infection. A new device was placed. No further patient complications have been reported.
 
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Brand NameLATITUDE ELBOW PROSTHESIS, ULNAR STEM, SMALL, RIGHT, 70MM
Type of DeviceELBOW PROSTHESIS
Manufacturer (Section D)
TORNIER INC.
10801 nesbit avenue south
bloomington MN 55437
Manufacturer Contact
dustin smith
10801 nesbit ave south
bloomington, MN 55437
9529217121
MDR Report Key5864948
MDR Text Key51736872
Report Number3004983210-2016-00034
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100562
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 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2017
Device Catalogue Number0030020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/10/2016 Patient Sequence Number: 1
Treatment
RADIAL STEM 6.5MM DIAMETER
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