NobelZygoma™ 38290 (UDI 07332747161618)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 45° 47.5mm · Class 2 · Implant
All models of NobelZygoma (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelZygoma implant, a dental implant anchored in the cheekbone, has 140 adverse event reports, with no deaths and 135 injuries. Most describe the implant failing to fuse with the bone, sometimes losing its hold later, along with instability during placement. 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
- 140
- Deaths reported
- 0
- Injuries reported
- 135
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 07332747161618), received between Dec 13, 2021 and Jul 1, 2026 — classified as 135 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (84 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 Osseointegrate84
- Loss of Osseointegration24
- Osseointegration Problem12
- Migration6
- Adverse Event Without Identified Device or Use Problem4
- Fracture4
- Contamination /Decontamination Problem2
- Device Markings/Labelling Problem2
Patient problems
- Failure of Implant90
- No Clinical Signs, Symptoms or Conditions38
- Pain12
- Unspecified Infection12
- Foreign Body In Patient6
- Implant Pain2
- Numbness2
Recent adverse event reports
The 25 most recent of 140 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25684265 ↗InjuryJul 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25684249 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25496530 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25496528 ↗InjuryJun 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25420424 ↗InjuryJun 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25420423 ↗InjuryMay 13, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166141 ↗InjuryMay 13, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166140 ↗InjuryApr 15, 2026Loss of Osseointegration
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24891202 ↗InjuryApr 15, 2026Loss of Osseointegration
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24891200 ↗InjuryMar 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541453 ↗InjuryMar 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541036 ↗InjuryFeb 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436097 ↗InjuryFeb 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436094 ↗InjuryFeb 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24353768 ↗InjuryFeb 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24353763 ↗InjuryFeb 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24353747 ↗InjuryFeb 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24353742 ↗InjuryJan 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24062342 ↗InjuryJan 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24062338 ↗InjuryDec 23, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23884764 ↗InjuryDec 23, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23884727 ↗InjuryDec 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23737795 ↗InjuryDec 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23737702 ↗InjuryOct 24, 2025Osseointegration Problem; Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23386103 ↗
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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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