OKTAGON Dental Implant BL NC 22010Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Narrow Connect Ø3.3x10mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI E0HM220101), received between Jul 24, 2020 and Jul 22, 2022 — classified as 8 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8 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 Osseointegrate8
Patient problems
- Inadequate Osseointegration7
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 9, 2022Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13712420 ↗InjuryMar 1, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 4, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 2, 2021Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY WAS NOT ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 11918998 ↗InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY WAS NOT ACHIEVED, A WIDER IMPLANT WAS SEATED.
Patient problems: Inadequate Osseointegration
MAUDE report 11736623 ↗InjuryJul 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
TRANSFER PART OF IMPLANT, COULDN'T BE REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 10318496 ↗
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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