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OKTAGON Dental Implant BL RC 22001Recalls & reported problems

Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Regular Connect Ø4.1x8mm · Class 2 · Implant

All models of OKTAGON Dental Implant BL RC (7)

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

Adverse event reports
5
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI E0HM220011), received between Mar 22, 2021 and Jul 22, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 18, 2026.

Most reported problems

Device problems

  • Failure to Osseointegrate5

Patient problems

  • Inadequate Osseointegration4
  • Failure of Implant1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 22, 2022Failure to Osseointegrate; Failure to Osseointegrate

    MISSING OSSEOINTEGRATION.

    Patient problems: Inadequate Osseointegration

    MAUDE report 15083482 ↗
  • InjuryMar 1, 2022Failure to Osseointegrate; Failure to Osseointegrate

    MISSING OSSEOINTEGRATION.

    Patient problems: Inadequate Osseointegration

    MAUDE report 13630377 ↗
  • MalfunctionNov 11, 2021Failure to Osseointegrate; Failure to Osseointegrate

    MISSING OSSEOINTEGRATION, BONE TYPE III.

    Patient problems: Failure of Implant

    MAUDE report 12793376 ↗
  • InjuryOct 22, 2021Failure to Osseointegrate; Failure to Osseointegrate

    MISSING OSSEOINTEGRATION.

    Patient problems: Inadequate Osseointegration

    MAUDE report 12681172 ↗
  • InjuryMar 22, 2021Failure to Osseointegrate; Failure to Osseointegrate

    MISSING OSSEOINTEGRATION.

    Patient problems: Inadequate Osseointegration

    MAUDE report 11538611 ↗

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

Sources and updates

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