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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS, HUMERAL SPOOL, MEDIUM, RIGHT
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TORNIER INC. LATITUDE ELBOW PROSTHESIS, HUMERAL SPOOL, MEDIUM, RIGHT Back to Search Results
Catalog Number DKY213
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 10/26/2018
Event Type  malfunction  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.
 
Event Description
It was reported that the patient underwent a revision to address the humeral stem/ spool screw out of the humeral stem.
 
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Brand Name
LATITUDE ELBOW PROSTHESIS, HUMERAL SPOOL, MEDIUM, RIGHT
Type of Device
ELBOW PROSTHESIS
Manufacturer (Section D)
TORNIER INC.
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
matt kennedy
10801 nesbitt ave s
bloomington, MN 55437
9526837482
MDR Report Key8082241
MDR Text Key128399585
Report Number3004983210-2018-00069
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 distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberDKY213
Was Device Available for Evaluation? No
Date Manufacturer Received11/06/2018
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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