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

Model Number 424-922LN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tooth Fracture (2428)

Event Date 12/11/2018

Event Type  Injury  

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 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
• Type of Device: METAL ORTHODONTIC BRACKET
• Manufacturer (Section D): ORTHO ORGANIZERS, INC; 1822 aston avenue; carlsbad CA 92008 7306
• Manufacturer Contact: mary pearman ; 1822 aston avenue; carlsbad, CA 92008
• MDR Report Key: 8204894
• MDR Text Key: 131702578
• Report Number: 2081322-2018-00003
• Device Sequence Number: 1
• Product Code: EJF
• UDI-Device Identifier: 00190707023287
• UDI-Public: 00190707023287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 424-922LN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 61