Brånemark System® 34735 (UDI 07332747160178)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Zygoma TiU 40mm · Class 2 · Implant
Quick summary
This Nobel Biocare Brånemark Zygoma TiU implant is a dental implant used to anchor replacement teeth in the upper jaw. Most of the 54 reports describe the implant failing to bond with the surrounding bone, or losing that bond after surgery, along with pain and infection; 52 reports involve injuries and no deaths. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 07332747160178), received between Dec 23, 2021 and Aug 7, 2026 — classified as 52 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (32 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate32
- Loss of Osseointegration14
- Osseointegration Problem4
- Adverse Event Without Identified Device or Use Problem2
- Device Damaged by Another Device2
Patient problems
- Failure of Implant44
- Pain16
- Unspecified Infection14
- No Clinical Signs, Symptoms or Conditions4
- Fistula2
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Loss of Osseointegration
InjuryAug 7, 2026Loss of Osseointegration
InjuryMar 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24599637 ↗InjuryMar 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24595921 ↗InjuryFeb 18, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24382418 ↗InjuryFeb 18, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24382398 ↗InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
InjuryDec 26, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 26, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20690861 ↗InjuryNov 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20690820 ↗InjuryNov 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20690323 ↗InjuryNov 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20690200 ↗InjuryJun 25, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19609406 ↗InjuryJun 25, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19609103 ↗InjuryApr 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19208203 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.