Brånemark System® 34724 (UDI 07332747013467)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Zygoma TiU 35mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Brånemark System Zygoma TiU implant is a root-form dental implant used in the upper jaw. The 65 reports mostly describe implants that fail to fuse properly with the surrounding bone or that lose that bond after healing, along with occasional breakage, pain, infection and sinus perforation. All 65 reports describe injuries, with no deaths. 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
- 65
- Deaths reported
- 0
- Injuries reported
- 65
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 07332747013467), received between Sep 11, 2019 and Mar 10, 2026 — classified as 65 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (27 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 Osseointegrate27
- Loss of Osseointegration24
- Fracture8
- Osseointegration Problem6
- Malposition of Device2
Patient problems
- Failure of Implant63
- Pain16
- Unspecified Infection7
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2026Failure to Osseointegrate
InjuryMar 10, 2026Failure to Osseointegrate
InjuryFeb 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 18, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19562400 ↗InjuryJun 18, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19562315 ↗InjuryJun 5, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19471728 ↗InjuryJun 5, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19471718 ↗InjuryNov 14, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18134761 ↗InjuryNov 14, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18134749 ↗InjuryNov 1, 2023Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 18050652 ↗InjuryNov 1, 2023Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 18050643 ↗InjuryNov 1, 2023Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 18050616 ↗InjuryNov 1, 2023Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 18050577 ↗InjuryJul 17, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 17336030 ↗InjuryJul 17, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 17335964 ↗InjuryMay 2, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 16857830 ↗InjuryMay 2, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 16856874 ↗InjuryMay 1, 2023Failure to Osseointegrate; Malposition of Device; Failure to Osseointegrate; Malposition of Device
IMPLANT FAILED DUE TO SINUS PERFORATION.
Patient problems: Failure of Implant; Sinus Perforation; Unspecified Infection
MAUDE report 16846997 ↗InjuryMay 1, 2023Failure to Osseointegrate; Malposition of Device; Failure to Osseointegrate; Malposition of Device
IMPLANT FAILED DUE TO SINUS PERFORATION.
Patient problems: Failure of Implant; Sinus Perforation; Unspecified Infection
MAUDE report 16846985 ↗InjuryApr 28, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 16835741 ↗InjuryApr 28, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 16835718 ↗InjuryApr 13, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16736482 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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