infinity OCTAGON 503308BLRecalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Narrow Connect Ø3,3x8 · Class 2 · Implant
All models of infinity OCTAGON (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI E0HM503308BL1), received between Jan 6, 2022 and Mar 15, 2024 — classified as 10 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate7
- Patient Device Interaction Problem6
- Osseointegration Problem2
- Loss of Osseointegration1
Patient problems
- Failure of Implant8
- Inadequate Osseointegration3
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryJul 5, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT WITH CROWN BECAME LOOSE. I PLAN TO RE-IMPLANT IN 3 MONTHS.
Patient problems: Failure of Implant
MAUDE report 17255775 ↗InjuryJun 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DIDN'T ACHEIVE ADEQUATE FRICTION AND STABILITY.
Patient problems: Failure of Implant
MAUDE report 17187556 ↗InjuryJun 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryJun 2, 2023Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Loss of Osseointegration; Osseointegration Problem; Patient Device Interaction Problem
MalfunctionMay 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryMay 16, 2023Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem; Failure to Osseointegrate; Osseointegration Problem; Patient Device Interaction Problem
InjuryApr 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 28, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT WAS NEVER TIGHT ENOUGH, WAS A SPINNER.
Patient problems: Failure of Implant
MAUDE report 13180145 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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