MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC CARRIERE MOTION 3D COLORS CLASS II 22MM LEFT-SILVER; METAL ORTHODONTIC BRACKET

Model Number	424-922LN
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was bonded on (b)(6) 2018.Instructions for debonding the device state that the protocol is to "orient the instrument toward the mesial aspect of the cuspid or bicuspid pad in an occlusal/gingival aspect.Gently squeeze, applying increased coninuous pressure, without any twisting or pulling until the bond fails." based on the input from the orthodontist's office, the device was removed using the protocol for removing a bracket, which likely would have included twisting and pulling motions.
Event or Problem Description
While dental hygienist was debonding orthodontic device, patient experienced an enamel fracture of upper left cuspid.

• Brand Name: CARRIERE MOTION 3D COLORS CLASS II 22MM LEFT-SILVER
• Common Device Name: METAL ORTHODONTIC BRACKET
• Manufacturer (Section D): ORTHO ORGANIZERS, INC; 1822 aston avenue; carlsbad CA 92008 7306
• MDR Report Key: 8204894
• Report Number: 2081322-2018-00003
• Device Sequence Number: 1592951
• Product Code: EJF
• UDI-Device Identifier: 00190707023287
• UDI-Public: 00190707023287
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 12/17/2018

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: Health Professional
• Device Model Number: 424-922LN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 12/28/2018
• 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: 40 YR
• Patient Weight: 61