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

Model Number 300-R2(XX)

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/19/2020

Event Type  Injury  

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 Description

While orthodontist was removing the bracket from tooth #8, the patient's tooth cracked.

• Brand Name: CLEAR-VIZ MINI BRACKET
• Type of Device: CERAMIC BRACKET
• Manufacturer (Section D): DYNAFLEX; 10403 intl plaza drive; st. ann, mo
• Manufacturer (Section G): DYNAFLEX; 10403 intl plaza drive; st. ann, mo
• Manufacturer Contact: maureen miller ; 10403 intl plaza drive; st. ann, mo ; 4264020132
• MDR Report Key: 10240550
• MDR Text Key: 197801479
• Report Number: 0001937100-2020-00001
• Device Sequence Number: 1
• Product Code: NJM
• UDI-Device Identifier: D841300XX18
• UDI-Public: D841300XX18
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 300-R2(XX)
• Device Catalogue Number: 300-R2(XX)
• Device Lot Number: 1965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/07/2020
• 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: 26 YR