OKTAGON Dental Implant BL RC 22002Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Regular Connect Ø4.1x10mm · 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
- 15
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI E0HM220021), received between Apr 18, 2019 and Aug 5, 2022 — classified as 13 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 Osseointegrate15
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration12
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION, INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15173014 ↗InjuryJul 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 1, 2022Failure to Osseointegrate; Failure to Osseointegrate
MISSING PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13635157 ↗MalfunctionOct 4, 2021Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionOct 4, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 30, 2021Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION DUE TO ALLERGIC REAKTION TO SUTURE MATERIAL.
Patient problems: Inadequate Osseointegration
MAUDE report 12553046 ↗InjuryJul 5, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 12115490 ↗InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 11736610 ↗InjuryMar 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
FISTULA WAS BUILDED, IMPLANT HAS TO BE REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 10318502 ↗InjuryJul 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
REMOVAL OF TRANSFER PART WASN'T POSSIBLE.
Patient problems: Inadequate Osseointegration
MAUDE report 10318500 ↗InjuryJul 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
NO OSSEOINTEGRATION DUE TO POOR ORAL HYGIENE, PERIIMPLANTITIS, AND A PREVIOUS AUGMENTATION.
Patient problems: Inadequate Osseointegration
MAUDE report 10318494 ↗InjuryJun 25, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 8730031 ↗InjuryApr 18, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT WAS REMOVED DUE TO POOR BONE QUALITY.
Patient problems: Inadequate Osseointegration
MAUDE report 8526340 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page