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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC. AEQUALIS HUMERAL NAIL SYSTEM INTRAMEDULLARY NAIL

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TORNIER INC. AEQUALIS HUMERAL NAIL SYSTEM INTRAMEDULLARY NAIL Back to Search Results
Catalog Number 0020500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Date 03/07/2017
Event Type  Injury  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event Description
It was reported that a patient underwent an arthroscopic debridement on (b)(6) 2017 due to post-operative stiffness and range of motion loss followed by a corticosteroid injection on (b)(6) 2017.
 
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Brand NameAEQUALIS HUMERAL NAIL SYSTEM
Type of DeviceINTRAMEDULLARY NAIL
Manufacturer (Section D)
TORNIER INC.
10801 nesbitt avenue south
bloomington MN 55437
Manufacturer Contact
matt kennedy
10801 nesbitt ave south
bloomington, MN 55437
9526837482
MDR Report Key7269436
MDR Text Key99997898
Report Number3004983210-2018-00002
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial
Report Date 04/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0020500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/20/2017
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: 02/14/2018 Patient Sequence Number: 1
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