Brånemark System® 34723 (UDI 07332747013450)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Zygoma TiU 30mm · 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 zygomatic dental implant has 42 adverse event reports, with no deaths and 40 injuries. Most reports describe the implant failing to fuse with the jawbone, or later losing that bond, sometimes with infection or pain; two mention fractures. No recalls name this device. Report volume dropped notably, from 16 in the earlier 12 months to 4 in the most recent year.
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
- 42
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07332747013450), received between Mar 24, 2020 and Apr 4, 2026 — classified as 40 injuries, 2 malfunctions.
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 Osseointegration13
- Fracture2
Patient problems
- Failure of Implant34
- Unspecified Infection11
- Pain8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2026Failure to Osseointegrate
InjuryApr 4, 2026Failure to Osseointegrate
InjuryDec 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23737616 ↗InjuryDec 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23737509 ↗InjuryJul 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22442598 ↗InjuryJul 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22442560 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22442542 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22442528 ↗MalfunctionMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 22, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20044490 ↗InjuryAug 22, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20040559 ↗InjuryMar 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18964862 ↗InjuryMar 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18964748 ↗InjuryOct 11, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15576534 ↗
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- 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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