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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC LATITUDE EV PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

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TORNIER INC LATITUDE EV PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Back to Search Results
Catalog Number 9030375
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
Device is not returned at this time. If additional information becomes available, it will be provided on a supplemental report.
 
Event Description
It was reported that during a revision surgery the tip of the driver broke off trying to loosen the ulna cap off of the loose ulna component. No patient complications were reported.
 
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Brand NameLATITUDE EV
Type of DevicePROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer (Section G)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
nathe hendricks
10801 nesbitt avenue s
bloomington, MN 55437
9524267600
MDR Report Key12328279
MDR Text Key266853878
Report Number3004983210-2021-00064
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9030375
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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