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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA); NAIL, FIXATION, BONE

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SYNTHES (USA); NAIL, FIXATION, BONE Back to Search Results
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Infiltration into Tissue (1931); No Code Available (3191)
Event Date 04/15/2014
Event Type  Injury  
Event Description
This report is being filed after the subsequent review of the following journal article: lu, c.-c.Et al (2014) complications and technical pitfalls of titanium elastic nail fixation for midclavicular fractures.Orthopedics 37(4), e377-e383.From january 2007 to april 2008, 27 patients (17 men, 10 women; mean age 45.8 years; range 16.5-66.9 years) with marked displaced midclavicular fractures underwent fixation with titanium elastic nails (synthes, (b)(4)).No infection, nonunion, nail dislocation, or implant breakage occurred and all procedures healed without secondary procedures.One patient experienced severe tip prominence/protrusion and bone shortening that required implant removal.This is report 4 of 4 for (b)(4).This complaint is for an unknown titanium elastic nail.This report is for 1 devices.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis lu, c.-c.Et al (2014) complications and technical pitfalls of titanium elastic nail fixation for midclavicular fractures.Orthopedics 37(4), e377-e383.This report is for an unknown titanium elastic nail.(b)(4).Bone shortening.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key4109072
MDR Text Key15814992
Report Number2520274-2014-13711
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/03/2014
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? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/03/2014
Initial Date FDA Received09/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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