Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHODONTIC WIRE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ORTHODONTIC WIRE Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Internal Organ Perforation (1987)
Event Date 04/01/2015
Event Type  Injury  
Event Description
My son, (b)(6), finished orthodontic treatment about 3 years ago, and was fitted with a small orthodontic wire, glued to the back of his front teeth, in order to prevent the teeth from migrating back to the original space.This was done by a very professional orthodontist, who uses only fda-approved materials and devices.A few days ago he was admitted to the hospital with extreme abdominal pain.Sonogram and ct imaging could not pick up anything, but his blood work indicated a severe infection.A second ct scan, done 4 days later, revealed a life-threatening puncture and infection of the stomach wall.During surgery, a thin wire - identified as an orthodontic wire, was pulled out: it had punctured the whole stomach wall - side to side.He is now hospitalized, getting 5 types of antibiotics (iv, obviously - he can't use his digestive system yet).I don't know who to contact in order to prevent this from happening to someone else, so i'm writing to you.I have the wire extracted from his stomach, and the orthodontist confirmed this was the wire used in his mouth.I can also supply ct images of the wire stuck in the stomach wall.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORTHODONTIC WIRE
Type of Device
ORTHODONTIC WIRE
MDR Report Key4684409
MDR Text Key5670505
Report NumberMW5042072
Device Sequence Number1
Product Code DZC
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 04/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Sequence Number1
Treatment
CTC MEDS: NONE; RX MEDS: NONE
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age19 YR
Patient Weight67
-
-