MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC. CARRIERE MOTION CLASS II; BRACKET, METAL, ORTHODONTIC

Model Number	424-925CN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The orthodontist removed as much composite as possible around ul3, ul6, ur4 and ur6.Once the excess composite was removed, the dental assistant used a bracket removing plier and squeezed between the bonding pad and tooth.A 1mm of incisal enamel ul3 was fractured.A small amount of flowable composite resin was bonded to the enamel fracture.Because the appliance was bonded to the very incisal edge of the facial surface, the orthodontist thought the enamel may have been too brittle at the edge of the tooth.Additionally, the orthodontist switched the bonding agents approximately 9 months ago due to excessive bond strengths he was experiencing, which may have led to the fractured enamel.Device not returned.
Event or Problem Description
Tooth fracture while debonding carriere motion appliance when removing the carriere from #11 tooth, the mesial edge of the tooth fractured off with the carriere.The patient is symptom free.

• Brand Name: CARRIERE MOTION CLASS II
• Common Device Name: BRACKET, METAL, ORTHODONTIC
• Manufacturer (Section D): ORTHO ORGANIZERS, INC.; 1822 aston avenue; carlsbad CA 92008
• MDR Report Key: 6599788
• Report Number: 2081322-2017-00002
• Device Sequence Number: 10782787
• Product Code: EJF
• UDI-Device Identifier: 00190707023362
• UDI-Public: 00190707023362
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/01/2017

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
• Operator of Device: Dental Assistant
• Device Model Number: 424-925CN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 YR
• Patient Weight: 45