Brånemark System® 34735 (UDI 07332747013474)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Zygoma TiU 40mm · Class 2 · Implant
Quick summary
This Nobel Biocare Brånemark System Zygoma implant has 87 reports in the FDA database, with no deaths and 87 injuries. Most reports describe the implant losing or failing to integrate with the bone, and some describe pain, infection or numbness. Reports rose to 8 in the past 12 months from 0 the year before. No recalls name 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
- 87
- Deaths reported
- 0
- Injuries reported
- 87
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 07332747013474), received between Sep 11, 2019 and Jun 11, 2026 — classified as 87 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (43 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
- Loss of Osseointegration43
- Failure to Osseointegrate36
- Fracture4
- Adverse Event Without Identified Device or Use Problem2
- Osseointegration Problem2
Patient problems
- Failure of Implant79
- Pain18
- Unspecified Infection7
- Abscess6
- Numbness6
- No Clinical Signs, Symptoms or Conditions2
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479609 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479599 ↗InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Failure to Osseointegrate
InjuryFeb 16, 2026Failure to Osseointegrate
InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19472099 ↗InjuryJun 5, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19471698 ↗InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19120270 ↗InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19120269 ↗InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19120244 ↗InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19120230 ↗InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19120229 ↗InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19120225 ↗InjuryApr 9, 2024Fracture; Fracture
InjuryApr 9, 2024Fracture; Fracture
InjuryOct 19, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17969330 ↗InjuryOct 19, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17969266 ↗InjuryOct 9, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 17898935 ↗InjuryOct 9, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED, DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 17898932 ↗InjuryAug 17, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17567786 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.