MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC CARRIERE MOTION CLASS II 17MM RIGHT; BRACKET, METAL, ORTHODONTIC

Model Number 424-917RN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tooth Fracture (2428)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

Instructions for use and quick start guide both specifically state that the cuspid or bicuspid pad is to be debonded first, followed by debonding the molar pad.In this instance, the device was removed by debonding the molar pad first, then attempting to debond the bicuspid pad.

Event Description

While the technician was removing carriere motion class ii 17 mm right device, maxillary 1st bicuspid fractured.In addition the tooth fracturing, the pliers that were being used were broken during the procedure.

• Brand Name: CARRIERE MOTION CLASS II 17MM RIGHT
• Type of Device: BRACKET, METAL, ORTHODONTIC
• Manufacturer (Section D): ORTHO ORGANIZERS, INC; 1822 aston avenue; carlsbad CA 92008 7306
• Manufacturer (Section G): ORTHO ORGANIZERS, INC; 1822 aston avenue; carlsbad CA 92008 7306
• Manufacturer Contact: mary pearman ; 1822 aston avenue; carlsbad, CA 92008
• MDR Report Key: 6843863
• MDR Text Key: 84945430
• Report Number: 2081322-2017-00004
• Device Sequence Number: 1
• Product Code: EJF
• UDI-Device Identifier: 00190707023140
• UDI-Public: 00190707023140
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Model Number: 424-917RN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 12 YR
• Patient Weight: 44