MAUDE Adverse Event Report: DYNAFLEX CLEAR-VIZ MINI BRACKET; CERAMIC BRACKET

Model Number	300-R2(XX)
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusive evidence has been provided that supports or opposes the fact that the bracket caused or contributed to the patient's injury.Dynaflex relabels and repackages the bracket which is originally manufactured by (b)(4) under the name (b)(4).510k is held by (b)(4).This is an isolated incident and dynaflex has not received any other complaints about tooth breakage associated with this product in the many years of sales.
Event or Problem Description
While orthodontist was removing the bracket from tooth #8, the patient's tooth cracked.

• Brand Name: CLEAR-VIZ MINI BRACKET
• Common Device Name: CERAMIC BRACKET
• Manufacturer (Section D): DYNAFLEX; 10403 intl plaza drive; st. ann, mo
• MDR Report Key: 10240550
• Report Number: 0001937100-2020-00001
• Device Sequence Number: 11437437
• Product Code: NJM
• UDI-Device Identifier: D841300XX18
• UDI-Public: D841300XX18
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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: 300-R2(XX)
• Device Catalogue Number: 300-R2(XX)
• Device Lot Number: 1965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/07/2020
• 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: 26 YR