Skip to content

Hex Tool Short HT2.5SRecalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307119708), received between Apr 30, 2018 and Sep 26, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

  • Device-Device Incompatibility1
  • Material Deformation1
  • Separation Failure1
  • Separation Problem1

Patient problems

  • Failure of Implant1
  • No Code Available1
  • No Consequences Or Impact To Patient1
  • No Information1
  • Osteopenia/ Osteoporosis1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 26, 2019Separation Failure; Material Deformation; Separation Failure; Material Deformation

    PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, IT WAS OBSERVED THAT THE COMPONENT COULD NOT BE SEPARATED.

    Patient problems: Failure of Implant; No Information

    MAUDE report 9121936 ↗
  • MalfunctionSep 6, 2018Separation Problem; Separation Problem

    PER COMPLAINT (B)(4), DURING THE OSTEOTOMY, THE IMPLANT BECAME STUCK MIDWAY. THE DOCTOR WAS UNABLE TO REMOVE THE IMPLANT WITHOUT DAMAGING THE IMPLANT OR INSTRUMENTS. THERE WAS NO ADVERSE IMPACT TO PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7853709 ↗
  • InjuryApr 30, 2018Device-Device Incompatibility; Device-Device Incompatibility

    DRIVERS STUCK TO IMPLANT AND REQUIRED SO MUCH FORCE TO DISENGAGE THAT IT REMOVED IMPLANT & COULDN'T BE ENGAGED AGAIN. IMPLANT WAS REMOVED AND A SECOND SURGERY WAS REQUIRED. THIS IS A REPORTABLE SERIOUS INJURY.

    Patient problems: No Code Available; Osteopenia/ Osteoporosis

    MAUDE report 7474594 ↗

Other Accessories, Implant, Dental, Endosseous devices

All Accessories, Implant, Dental, Endosseous devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page