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

Model Number	424-925LN
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: DISTALIZER
• Manufacturer (Section D): ORTHO ORGANIZERS, INC; 1822 aston avenue; carlsbad CA 92008 7306
• MDR Report Key: 8009692
• Report Number: 2081322-2018-00001
• Device Sequence Number: 168552
• Product Code: EJF
• UDI-Device Identifier: 00190707023379
• UDI-Public: 00190707023379
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/08/2018

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: Other
• Device Model Number: 424-925LN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRANSBOND ADHESIVE - 3M UNITEK
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 13 YR
• Patient Weight: 59