infinity OCTAGON 503312BLRecalls & reported problems
Hager & Meisinger Gesellschaft mit beschränkter Haftung · Bone Level Implant Narrow Connect Ø3.3x12 · Class 2 · Implant
All models of infinity OCTAGON (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI E0HM503312BL1), received between Dec 18, 2020 and Sep 9, 2024 — classified as 7 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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 Osseointegrate4
- Loss of Osseointegration3
- Osseointegration Problem1
Patient problems
- Failure of Implant5
- Unspecified Infection3
- Inadequate Osseointegration2
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjurySep 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2023Loss of Osseointegration; Loss of Osseointegration
ACUTE INFECTION AT ONE MONTH.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17628031 ↗InjuryAug 25, 2023Loss of Osseointegration; Loss of Osseointegration
INFECTION #10 AT 1 MONTH.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17627376 ↗InjuryMay 17, 2023Failure to Osseointegrate; Failure to Osseointegrate
INTEGRATED 4+ MONTHS. FINAL REST TORQUE PT. PAIN & MOBILE.
Patient problems: Failure of Implant
MAUDE report 16950152 ↗InjuryDec 18, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
INFECTION, PAIN, BLEEDING AND SWELLING WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 11037757 ↗
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- 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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