Neodent 103.619Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · LATERAL CUT DRILL ZYGOMA-S · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07899878059820), received between Aug 18, 2026 and Aug 18, 2026 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Foreign Body In Patient1
- Inflammation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
A complaint was received n which the customer reported an intraoperative incident involving item 103.619 (Multifluted Zygoma-S Bur, lot YKWX5). According to the practitioner's report, the multifluted bur fractured, resulting in the bur becoming lodged within the patient's left maxillary sinus. However, the Product Safety Management and Product Research & Development departments conducted the relevant investigations and concluded that the item's drilling guide pin had unscrewed and detached.
Patient problems: Foreign Body In Patient; Inflammation
MAUDE report 50307340 ↗
Other DRILL, DENTAL, INTRAORAL devices
- Neodent 103.170JJGC Indústria e Comércio de Materiais Dentários S/A. · DRILL, DENTAL, INTRAORAL1 recall0 reports
- ParaPost Fiber White PF180Coltene/Whaledent Inc · Drill, Dental, Intraoral1 report
- Neodent 103.162JJGC Indústria e Comércio de Materiais Dentários S/A. · DRILL, DENTAL, INTRAORAL1 report
- ParaPost Fiber Lux PF170Coltene/Whaledent Inc · Drill, Dental, Intraoral1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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