NobelZygoma™ 38280 (UDI 07332747161519)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 0° 45mm · Class 2 · Implant
All models of NobelZygoma (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Zygoma dental implant is a dental implant. Reports mostly describe implants not joining to the bone and failing, with numbness and pain mentioned. There are 26 reports naming its identifier, with no deaths and 24 injuries. 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
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07332747161519), received between Apr 14, 2022 and Sep 10, 2026 — classified as 26 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (20 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 Osseointegrate20
- Adverse Event Without Identified Device or Use Problem4
- Fracture2
- Material Deformation2
Patient problems
- Failure of Implant24
- Numbness8
- Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bone Fracture(s)2
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection2
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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724402 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724400 ↗InjuryFeb 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24263148 ↗InjuryFeb 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24263144 ↗InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 30, 2024Fracture; Fracture
InjuryDec 30, 2024Fracture; Fracture
InjurySep 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness
MAUDE report 20184266 ↗InjurySep 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness
MAUDE report 20184144 ↗InjurySep 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness
MAUDE report 20184117 ↗InjurySep 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness
MAUDE report 20184115 ↗InjurySep 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20176828 ↗InjurySep 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20175478 ↗InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20079256 ↗InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20079246 ↗InjuryAug 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19923212 ↗InjuryAug 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19922986 ↗InjuryAug 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19922813 ↗InjuryAug 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19922762 ↗InjuryFeb 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18636283 ↗InjuryFeb 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE
Patient problems: Failure of Implant
MAUDE report 18635482 ↗InjuryOct 29, 2022Material Deformation; Material Deformation
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 15694852 ↗MalfunctionOct 28, 2022Material Deformation; Material Deformation
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 15693395 ↗InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IMPLANT FAILED DUE TO BONE FRACTURE.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 15078304 ↗
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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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