OKTAGON Dental Implant BL RC 22006Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Regular Connect Ø4.8x10mm · 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
- 17
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI E0HM220061), received between Apr 18, 2019 and Aug 5, 2022 — classified as 16 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (17 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 Osseointegrate17
Patient problems
- Inadequate Osseointegration12
- No Clinical Signs, Symptoms or Conditions4
- Failure of Implant1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15173013 ↗InjuryAug 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION, POSSIBLE HIGH LOAD OF PROVISIONAL PROSTHESIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15173010 ↗InjuryMar 9, 2022Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13712380 ↗InjuryFeb 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13575565 ↗MalfunctionNov 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 4, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 27, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 7, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT SPUN WHEN DENTIST WANT TO TORQUE ABUTMENT.
Patient problems: Inadequate Osseointegration
MAUDE report 11736629 ↗InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
EXPLANTATION OF IMPLANT DUE TO MISSING OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 11736611 ↗InjuryJul 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
INADEQUATE BONE QUALITY FOR IMPLANT PLACEMENT.
Patient problems: Inadequate Osseointegration
MAUDE report 8623364 ↗InjuryApr 18, 2019Failure to Osseointegrate; Failure to Osseointegrate
INADEQUATE BONE FOR PRIMARY STABILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 8526337 ↗InjuryApr 18, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO PRIMARY STABILITY WAS ACHIEVED DUE TO A INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 8526334 ↗InjuryApr 18, 2019Failure to Osseointegrate; Failure to Osseointegrate
INADEQUATE PRIMARY STABILITY DUE TO AN INADEQUATE BONE QUALITY/QUANTITY.
Patient problems: Inadequate Osseointegration
MAUDE report 8526333 ↗
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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