NobelZygoma™ 38282 (UDI 07332747102727)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 0° 50mm · Class 2 · Implant
All models of NobelZygoma (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07332747102727), received between Sep 11, 2019 and Jun 13, 2023 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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.
Most reported problems
Device problems
- Failure to Osseointegrate3
- Adverse Event Without Identified Device or Use Problem2
- Osseointegration Problem2
Patient problems
- Failure of Implant7
- Pain3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 17120289 ↗InjuryJun 13, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 17120286 ↗InjuryJan 28, 2022Adverse 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. THEMALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 13387655 ↗MalfunctionJan 28, 2022Adverse 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 13387642 ↗InjuryJan 9, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9567818 ↗InjurySep 12, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9004974 ↗InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 8994369 ↗
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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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