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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INCAEQUALIS FRACTURE IMPLANT UNKNOWNNONE

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TORNIER INC AEQUALIS FRACTURE IMPLANT UNKNOWN NONE   Back to Search Results
Event Type  Injury   Patient Outcome  Required Intervention
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.

 
Event Description

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

 
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Brand NameAEQUALIS FRACTURE IMPLANT UNKNOWN
Type of DeviceNONE
Manufacturer (Section F)
TORNIER INC
montbonnot
FRANCE
Manufacturer (Section D)
TORNIER INC
montbonnot
FRANCE
Manufacturer (Section G)
TORNIER SAS
161 rue lavoisier
montbonnot cedex
FRANCE 38334
Manufacturer Contact
kevin smith
10801 nesbitt ave s
bloomington , MN 55437
(952) 921 -7121
Device Event Key3005319
MDR Report Key2977943
Event Key2874457
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
Was The Report Sent To Manufacturer? 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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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