InjuryDZP
SOLO DIAMOND
Received Apr 12, 2023 · Event occurred Mar 16, 2023
Report 2511556-2023-00001 · MDR key 16724202
Device
Generic name
Diamond, Dental Burr
Manufacturer
Premier Dental Products CompanyModel number
2137CCatalog number
811037C
Lot number
MO112448
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
Unknown
- Tooth Fracture
- Tooth Fracture
Narrative
Description of Event or Problem
DENTIST INSERTED PREMIER'S SOLO DIAMOND BUR (SKU: 811037C) INTO A YABANGBANG HANDPIECE AND TESTED OUTSIDE OF THE PATIENT'S MOUTH WITHOUT ISSUE. THE DENTIST PROCEEDED TO CU A CROWN PREP ON TOOTH #30. THE BURR BENT IMMEDIATELY AND CUT INTO ADJACENT TOOK #29 AND FRACTURED IT. PATIENT IS FINE NOW BUT WILL NEED A ROOT CANAL AND CROWN.
Additional Manufacturer Narrative
DENTIST USED A HIGH-SPEED HANDPIECE WHICH OPERATED AT A HIGHER RPM WHICH WAS CONTRAINDICATED FOR THE USE OF PREMIER'S SOLO DIAMOND BURR.