NobelZygoma™ 38281 (UDI 07332747161526)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 0° 47.5mm · Class 2 · Implant
All models of NobelZygoma (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07332747161526), received between Nov 1, 2021 and Aug 8, 2025 — classified as 7 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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
- Adverse Event Without Identified Device or Use Problem2
- Failure to Osseointegrate2
- Fracture2
- Loss of Osseointegration2
- Premature Separation2
Patient problems
- Failure of Implant8
- Unspecified Infection2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 4, 2023Premature Separation; Premature Separation
THE IMPLANT MALFUNCTIONED DUE TO PART NOT RETAINED ON MATING PART (E.G.,. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 18259344 ↗MalfunctionDec 4, 2023Premature Separation; Premature Separation
THE IMPLANT MALFUNCTIONED DUE TO PART NOT RETAINED ON MATING PART E.G. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 18259324 ↗MalfunctionSep 28, 2023Fracture; Fracture
THE IMPLANT MALFUNCTIONED DUE TO PART FRACTURED. THE MALFUNCTION DID NOTCAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 17838426 ↗InjurySep 28, 2023Fracture; Fracture
THE IMPLANT MALFUNCTIONED DUE TO PART FRACTURED. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 17838317 ↗MalfunctionFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE IMPLANT MALFUNCTIONED DUE TO DROPPING FROM THE IMPLANT DRIVER. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 16297608 ↗InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE IMPLANT MALFUNCTIONED DUE TO DROPPING FROM THE IMPLANT DRIVER. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 16297590 ↗InjuryNov 1, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12732440 ↗InjuryNov 1, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12732425 ↗
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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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