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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 Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Date 01/17/2018
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 complained of feeling a prominence along the anterior aspect of the shoulder that was sometimes painful. Radiographs revealed that the prominence was the calcar screw. The patient had an outpatient procedure to remove this screw 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 Key7720028
MDR Text Key115060750
Report Number3004983210-2018-00036
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 Non-Healthcare Professional
Type of Report Initial
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0020600
Device Lot NumberBP0315313
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
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: 07/25/2018 Patient Sequence Number: 1
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