MAUDE Adverse Event Report: AMERICAN ORTHODONTICS ELASTICS GALAPAGOS GIANT TORTOISE, QTY 100, 6 1/2 OZ, SIZE 3/16'', HEAVY, 4.8 MM; BAND, ELASTIC, ORTHODONTIC

Model Number 000-121BAG

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Event Description

I am wearing braces on my teeth.My orthodontist prescribed elastics by american orthodontics.They are heavy, 4.8 mm, and have a green sea turtle on the packaging.The first batch of elastics varied greatly in thickness than the second and third batch.The first batch had much thinner elastics than the second and third batch.When i was wearing the elastics from the first batch, my mouth opened much wider, and the elastics were much easier to apply and did not slip easily from my fingertips when attaching them to brackets on maxillary and mandibular teeth.I noticed a huge difference in the thickness of elastics when my orthodontist gave me a second and third batch of elastics.These are very thick compared to the first batch and more difficult to apply.They also keep my jaw tighter together than the first batch did because they do not stretch so much.At (b)(6) university, i learned that manufacturers must have quality control in place to produce consistent product quality; the elastics should not vary in quality from one production date to another.As a result of the poor manufacturing practices of american orthodontics, my orthodontist asked me to wear the elastics on the right side of my mouth for 24 hours and on the left for 12 hours only.The inconsistency in elastic manufacturing practices led to my bite not being aligned equally after 12 weeks of treatment.I wore the elastics exactly as prescribed - 8 hours a day for the first six weeks on both sides and 24 hours a day for the next six weeks on both sides.Now, i have to wear the elastics 12 hours a day only on the left side and 24 hours on the right side.I want the fda to step in and protect me as a consumer because having a bad bite has profound consequences on a patient's self-confidence, beauty, and oral and systemic health.I want to protect other consumers from inconsistent manufacturing practices.Thank you! (b)(6).(b)(4).The other numbers on the label are (b)(4) and (b)(4).Reference reports: mw5145167, mw5145169.

• Brand Name: ELASTICS GALAPAGOS GIANT TORTOISE, QTY 100, 6 1/2 OZ, SIZE 3/16'', HEAVY, 4.8 MM
• Type of Device: BAND, ELASTIC, ORTHODONTIC
• Manufacturer (Section D): AMERICAN ORTHODONTICS
• MDR Report Key: 17690023
• MDR Text Key: 322959439
• Report Number: MW5145168
• Device Sequence Number: 1
• Product Code: ECI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 000-121BAG
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ELASTICS GALAPAGOS GIANT TORTOISE 4.8 MM, HEAVY ; HAND-HELD WATERPIK FOR ON-THE-GO MAINTENANCE OF MY TEETH AND SMILE ; I HAVE TWO PINK BRAIDS ON MY TEETH: ONE ON MY MAXILLARY TEETH AND THE SECOND ON MY MANDIBULAR TEETH. THEY ARE SEPARATING MY TEETH. ; I WEAR A LITTLE SPRING THAT ATTACHES MY BRACKETS ON TEETH #2 AND 3 TO THE TEMPORARY ANCHORAGE DEVICE.; I WEAR A PALATAL EXPANDER TO BROADEN MY SMILE.; I WEAR CERAMIC BRACES ON MY UPPER AND LOWER TEETH TO ALIGN MY BITE DISTORTED BY BAD CLINICIANS FROM (B)(6)FACULTY PRACTICE, THE UNIVERSITY OF (B)(6), (B)(6) UNIVERSITY, AND (B)(6) UNIVERSITY.; ORAL B TOOTHBRUSH WITH DUAL CLEAN BRUSH HEAD, 3D WHITE BRUSH HEAD, AND CROSS ACTION FLOSSING BRUSH HEAD. ; THE ORTHODONTIST GAVE ME A TEMPORARY ANCHORAGE DEVICE (A MINI IMPLANT) IN MY PALATE TO MOVE TEETH #2 AND 3 IN THE ALVEOLAR BONE BECAUSE THEY ARE SUPRAERUPTED FROM BAD DENTISTRY I RECEIVED AT HARVARD FACULTY PRACTICE. ; WHITENING WATERPIK
• Patient Sex: Female
• Patient Weight: 54 KG