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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC AEQUALIS FRACTURE IMPLANT UNKNOWN NONE

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TORNIER INC AEQUALIS FRACTURE IMPLANT UNKNOWN NONE Back to Search Results
Event Type  Injury  
Event Description

Pt failed their initial hemiarthroplasty due to lack of tuberosity healing and was revised to reverse total shoulder arthroplasty.

 
Manufacturer Narrative

Krishnan, s. G. , j. R. Reineck, et al. (2011). Shoulder arthroplasty for fracture: does a fracture-specific stem make a difference? clinical orthopaedics and related research 469 (12): 3317-3323. This is the final report submitted regarding this surgical event and medical device.

 
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Brand NameAEQUALIS FRACTURE IMPLANT UNKNOWN
Type of DeviceNONE
Manufacturer (Section D)
TORNIER INC
montbonnot
FRANCE
Manufacturer (Section G)
TORNIER SAS
161 rue lavoisier
montbonnot cedex 3833 4
FRANCE 38334
Manufacturer Contact
kevin smith
10801 nesbitt ave s
bloomington , MN 55437
(952) 952 -9529
95292171 9529217121
MDR Report Key2977943
Report Number9610667-2013-00064
Device Sequence Number1
Product CodeKWS
Report Source Manufacturer
Source Type Literature
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/24/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/24/2013
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: 02/21/2013 Patient Sequence Number: 1
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