MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC CARRIERE MOTION 3D COLORS CLASS II 25MM LEFT - SILVER; DISTALIZER

Model Number 424-925LN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tooth Fracture (2428)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

Instructions for use (ins 181a rev c) and quick start guide (999-329 rev a) both specifically state in step 4 of removal process: take one of the recommended removal instruments and place the tip ends at the adhesive interface (concave channel) between the motion 3d appliance cuspid pad and the tooth surface.Orient the instrument toward the mesial aspect of the cuspid or bicuspid pad in an occlusal/gingival aspect.Gently squeeze, applying increased continuous pressure, without any twisting or pulling until the bond fails.In this instance, the dentist stated that the sides of the pad of the device was used.In addition, examination of the returned product has evidence of tool marks on the product, not on the adhesive interface.

Event Description

While the technician was removing carriere motion 3d colors class ii 25mm left - silver, upper left 3 canine fractured.Per the dentist, the following steps were taken: removal of excess adhesive with high speed hand piece; having patient bite on cotton roll; squeezing on each side of pad with bracket removing plier.Device was bonded on (b)(6) 2018 and was being debonded due to the patient being finished with the treatment step.

• Brand Name: CARRIERE MOTION 3D COLORS CLASS II 25MM LEFT - SILVER
• Type of Device: DISTALIZER
• 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: 8009692
• MDR Text Key: 125158767
• Report Number: 2081322-2018-00001
• Device Sequence Number: 1
• Product Code: EJF
• UDI-Device Identifier: 00190707023379
• UDI-Public: 00190707023379
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 424-925LN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: TRANSBOND ADHESIVE - 3M UNITEK
• Patient Outcome(s): Disability
• Patient Age: 13 YR
• Patient Weight: 59