DLC Cortical Bone Drill 3.7mmD Implant CBD3.7CRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 2
Data updated Oct 18, 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 10841307124887), received between Aug 4, 2023 and Aug 4, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2023Fracture; Fracture
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.
Patient problems: Failure of Implant; Pain
MAUDE report 17459202 ↗
Other Drill, Bone, Powered devices
- NA 03.505.004Synthes GmbH · DRILL, BONE, POWERED69 reports
- Nobel Biocare® 37470Nobel Biocare AB · DRILL, BONE, POWERED1 recall0 reports
- MatrixMANDIBLE 03.503.476Synthes GmbH · DRILL, BONE, POWERED26 reports
- NA 310.510Synthes GmbH · DRILL, BONE, POWERED17 reports
- NA 317.82Synthes GmbH · DRILL, BONE, POWERED16 reports
- MatrixMANDIBLE 03.503.479Synthes GmbH · DRILL, BONE, POWERED11 reports
- NA 05.001.120Synthes GmbH · DRILL, BONE, POWERED9 reports
- NA 310.520Synthes GmbH · DRILL, BONE, POWERED9 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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