Hex Drill HD1.25Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307119548), received between Jul 3, 2019 and Sep 26, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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 16, 2026.
Most reported problems
Device problems
- Fracture2
- Break1
- Separation Problem1
Patient problems
- Failure of Implant3
- Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2022Fracture; Fracture
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, THE HEX DRILL STUCK IN THE HEAL ABUTMENT.
Patient problems: Failure of Implant
MAUDE report 15485837 ↗InjurySep 26, 2022Fracture; Fracture
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, THE HEX DRILL STUCK IN THE HEAL ABUTMENT.
Patient problems: Failure of Implant
MAUDE report 15485806 ↗InjuryJul 3, 2019Break; Separation Problem; Break; Separation Problem
PER COMPLAINT (B)(4), A HEX TOOL BROKE WITHIN A DENTAL IMPLANT DURING THE IMPLANT PROCEDURE. THE TOOL WAS STUCK WITHIN THE TOP PART OF THE IMPLANT. THE PATIENT'S BONE WAS DRILLED AS A CONSEQUENCE.
Patient problems: Failure of Implant; Injury
MAUDE report 8761131 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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