NobelZygoma™ 38279 (UDI 07332747161502)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 0° 42.5mm · Class 2 · Implant
All models of NobelZygoma (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This NobelZygoma dental implant is anchored in the cheekbone to support teeth. The 26 reports mostly describe implants that did not bond with bone or lost their bond, sometimes with infection and pain, and mention 26 injuries and 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07332747161502), received between Apr 20, 2023 and Sep 10, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (14 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate14
- Patient Device Interaction Problem6
- Loss of Osseointegration4
- Activation, Positioning or Separation Problem2
- Osseointegration Problem2
Patient problems
- Failure of Implant10
- No Clinical Signs, Symptoms or Conditions8
- Unspecified Infection8
- Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50724415 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50724413 ↗InjuryApr 21, 2026Loss of Osseointegration
InjuryApr 21, 2026Loss of Osseointegration
InjuryApr 21, 2026Loss of Osseointegration
InjuryApr 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24947435 ↗InjuryApr 21, 2026Loss of Osseointegration
InjuryApr 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24947428 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 17, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22536557 ↗InjuryJul 17, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22536311 ↗InjurySep 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20240969 ↗InjurySep 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20240928 ↗InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 20079179 ↗InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 20079166 ↗InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 20079104 ↗InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 20079027 ↗InjuryJun 7, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
InjuryJun 7, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
InjuryApr 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19138466 ↗InjuryApr 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19138422 ↗InjurySep 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17673012 ↗InjurySep 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17673000 ↗InjuryJul 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17408745 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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