CLEAR-VIZ MINI BRACKET
Received Jul 7, 2020 · Event occurred Jun 19, 2020
Report 0001937100-2020-00001 · MDR key 10240550
Device
Generic name
Ceramic Bracket
Manufacturer
DynaflexModel number
300-R2(XX)Catalog number
300-R2(XX)
Lot number
1965
Product problems
- Activation, Positioning or Separation Problem
- Activation, Positioning or Separation Problem
Patient
26 YR
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
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.
Description of Event or Problem
WHILE ORTHODONTIST WAS REMOVING THE BRACKET FROM TOOTH #8, THE PATIENT'S TOOTH CRACKED.
Remedial action
- Patient Monitoring