NobelZygoma™ 38278 (UDI 07332747161496)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 0° 40mm · 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 a root-form screw placed into the jawbone to support replacement teeth. Most of the 28 reports describe the implant failing to bond with the surrounding bone, or losing that bond after it had formed, along with a few fractures and cases of pain or infection; 26 people were injured and no deaths were reported. Reports filed in the past 12 months number 2, down from 12 in the prior 12 months. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 07332747161496), received between Jul 21, 2022 and Sep 11, 2026 — classified as 28 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (18 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 Osseointegrate18
- Loss of Osseointegration6
- Fracture4
- Patient Device Interaction Problem2
Patient problems
- Failure of Implant22
- Unspecified Infection4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Clinical Signs, Symptoms or Conditions2
- Pain2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50743901 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50743899 ↗InjuryJun 11, 2026Loss of Osseointegration
InjuryJun 11, 2026Loss of Osseointegration
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 22451811 ↗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 22451810 ↗InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 21, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 21, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 28, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 28, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 15, 2024Fracture; Fracture
THE IMPLANT MALFUNCTIONED DUE TO IT FRACTURING DURING PLACEMENT. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 19994706 ↗MalfunctionAug 15, 2024Fracture; Fracture
THE IMPLANT MALFUNCTIONED DUE TO IT FRACTURING DURING PLACEMENT. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 19994701 ↗InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17616120 ↗InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17616117 ↗InjuryJul 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17418742 ↗InjuryJul 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17418741 ↗InjuryJul 11, 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 17300856 ↗InjuryJul 11, 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 17300851 ↗InjuryOct 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15555433 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page