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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided for reporting. Date of event is unknown. This report is for unknown quantity of unknown titanium elastic nail (ten). Part#, lot# and udi # is not available. Device is not expected to be returned for manufacturer review/investigation. This report is for unknown quantity of unknown titanium elastic nail (ten). 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. (b)(4).
Event Description
This report is being filed after the review of the following journal article: mortier, d. And ridder, d. (2008), flexible intramedullary nailing in the treatment of diaphyseal fractures of the femur in prescholl children, acta orthopædica belgica, vol. 74 no. 2, pages 190-194 (belgium) the aim of this retrospective study is to illustrate that in this particular age group, intramedullary nailing is safe and valuable alternative compared to conservative treatment. A total of 9 patients (7 male and 2 female) with a mean age of 46. 2 months (range: 19-70 months) were treated with unknown synthes 2 titanium elastic nails (ten). All patients were evaluated clinically and radiographically 6 weeks postoperatively. The mean follow-up was 18. 9 months (range: 3-38 months). The following complications were reported as follows: all patients showed irritation due to the subcutaneous position of the nails. This report is for unknown quantity of unknown titanium elastic nail (ten). This is report 1 of 1 for (b)(4).
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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 Key7922089
MDR Text Key122172542
Report Number8030965-2018-56847
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2018
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 Received09/06/2018
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/01/2018 Patient Sequence Number: 1