OKTAGON Dental Implant BL RC 22003Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Regular Connect Ø4.1x12mm · 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
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI E0HM220031), received between Jul 24, 2020 and Sep 23, 2021 — classified as 9 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (9 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 Osseointegrate9
Patient problems
- Inadequate Osseointegration9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
FAILURE OF IMPLANT TO OSSEOINTEGRATE DUE TO POOR HYGIENE AND PERIIMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 12518847 ↗InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT SPUN WHEN DENTIST WANT TO TORQUE ABUTMENT.
Patient problems: Inadequate Osseointegration
MAUDE report 11736635 ↗InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
EXPLANTATION OF IMPLANT DUE TO MISSING OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 11736621 ↗InjuryMar 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION DUE TO IMPLANTITIS.
Patient problems: Inadequate Osseointegration
MAUDE report 11538596 ↗InjuryFeb 5, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
NO PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 10318490 ↗InjuryJul 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION, MAYBE A RESULT OF POOR ORAL HYGIENE AND A INADEQUATE BONE QUALITY / BONE QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 10318488 ↗InjuryJul 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 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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