OKTAGON Dental Implant BLT RC 24002Recalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Tapered Implant Regular Connect Ø4.1 x 10mm · Class 2 · Implant
All models of OKTAGON Dental Implant BLT RC (6)
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 E0HM240021), 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” (11 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 Osseointegrate11
- Unstable2
- Inadequacy of Device Shape and/or Size1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Inadequate Osseointegration9
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
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 DUE TO INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15173011 ↗InjuryJun 2, 2022Unstable
MISSING PRIMARYSTABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14572700 ↗InjuryJun 2, 2022Unstable
MISSING PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14572696 ↗InjuryMar 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
MISSING OSSEOINTEGRATION, POTENTIAL BIOMECHANICAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13575564 ↗MalfunctionOct 4, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 1, 2021Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionSep 23, 2021Therapeutic or Diagnostic Output Failure
IMPLANT FALL INTO VIAL DUE TO CUSTOMER FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12518891 ↗InjuryApr 28, 2021Inadequacy of Device Shape and/or Size
InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
SURGEON NEEDED A DIFFERENT SIZE.
Patient problems: Inadequate Osseointegration
MAUDE report 11736618 ↗InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
SURGEON NEEDED A DIFFERENT SIZE.
Patient problems: Inadequate Osseointegration
MAUDE report 11736616 ↗InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY WAS NOT ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 11736609 ↗InjuryApr 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY WAS NOT ACHIEVED.
Patient problems: Inadequate Osseointegration
MAUDE report 11736607 ↗InjuryJul 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 18, 2019Failure to Osseointegrate; Failure to Osseointegrate
PRIMARY STABILITY WASN'T ACHIEVED, IMPLANT WAS A SPINNER. DUE TO BONE TYPE I NO SITE WAS TAPPED. THE IMPLANT WAS REMOVED AND A 4.8X10 BLT WAS INSERTED DURING SURGERY.
Patient problems: Inadequate Osseointegration
MAUDE report 8526342 ↗
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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