MAUDE MDR 4684409

MDR report key
4684409
Report number
MW5042072
Event key
0
Event type
3
Date of event
2015-04-01
Date received
2015-04-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ORTHODONTIC WIREORTHODONTIC WIREDZC

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-0601. H; 2. L

Event Narratives#

D

Patient 1

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.