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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS, ULNAR CAP MEDIUM
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TORNIER INC. LATITUDE ELBOW PROSTHESIS, ULNAR CAP MEDIUM Back to Search Results
Catalog Number DKY068
Device Problem Misconnection (1399)
Patient Problem No Code Available (3191)
Event Date 06/15/2018
Event Type  malfunction  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event Description
It was reported that the patient underwent extended surgical time due to the placement of the screw that "does not catch the thread" and spreads the cap of the ulnar stem.It took some extended time for the surgeon to be able to get the screw to catch appropriately.The issue cause extended operating time, therefore tourniquet time and anesthesia time.
 
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Brand Name
LATITUDE ELBOW PROSTHESIS, ULNAR CAP MEDIUM
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 Key7682823
MDR Text Key113878346
Report Number3004983210-2018-00029
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00846832010912
UDI-Public00846832010912
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K100562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDKY068
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2018
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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