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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Irritation (2076); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided for reporting. Date of event is unknown. This report is for three (3) unknown titanium elastic nails. Part#, lot# and udi # is not available. Device is not expected to be returned for manufacturer review/investigation. This report is for three (3) unknown titanium elastic nails. Pma/510(k) number is not available. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event Description
This report is being filed after the review of the following journal article: varga m. , jozsa g. , fagyas b. , kassai t. , renner a. (2017) short, double elastic nailing of severely displaced distal pediatric radial fractures-a new method for stable fixation. Medicine. Volume 96. Number 14. Pages 1-5. (hungary) the aim of this technical report is to introduce the modified elastic stable intramedullary nailing (esin) method for operative treatment of severely displaced pediatric distal metaphyseal or metadiaphyseal radial fracture and to evaluate the final results of the procedure. Between november 2012 and december 2015, 24 patients who presented with closed fractures with total radial or dorsal displacement and shortening were included. There were 17 male and 7 female with ages from 6 to 16 years old. All fractures were stabilized using two short and prebent unknown synthes titanium elastic nails. All procedures were performed under general anesthesia. Three patients presented irritation of the skin, which resolved after a relatively early removal of the radial nail. This report is for three (3) unknown titanium elastic nails. This is report 1 of 1 for (b)(4). A copy of the literature article is being submitted with this medwatch.
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
MDR Report Key7496386
MDR Text Key107663755
Report Number8030965-2018-53633
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeHU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/08/2018 Patient Sequence Number: 1