MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD,FIXATION,INTRAMEDULLARY

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).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7922089
• MDR Text Key: 122172542
• Report Number: 8030965-2018-56847
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention