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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 0020600
Device Problems Activation, Positioning or SeparationProblem (2906); Unintended Movement (3026)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/07/2015
Event Type  Injury  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event Description
It was reported that the patient had a post operative complication of fracture displacement. Patient id: (b)(6). No other effects noted in report.
 
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Brand NameAEQUALIS HUMERAL NAIL SYSTEM
Type of DeviceINTRAMEDULLARY NAIL
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 Key8132540
MDR Text Key129305698
Report Number3004983210-2018-00077
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 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0020600
Device Lot NumberCA5207811
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2018
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 Treatment Data
Date Received: 12/05/2018 Patient Sequence Number: 1
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