NobelZygoma™ 38289 (UDI 07332747161601)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 45° 45mm · Class 2 · Implant
All models of NobelZygoma (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This NobelZygoma implant has 230 adverse event reports, including 220 injuries and no deaths. The reports mostly describe the implant failing to bond with the bone, bonding being lost over time, and 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
- 230
- Deaths reported
- 0
- Injuries reported
- 220
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 07332747161601), received between Nov 15, 2021 and Jul 8, 2026 — classified as 220 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (136 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 Osseointegrate136
- Loss of Osseointegration32
- Osseointegration Problem32
- Fracture14
- Activation, Positioning or Separation Problem6
- Migration4
- Adverse Event Without Identified Device or Use Problem2
- Material Deformation2
Patient problems
- Failure of Implant164
- No Clinical Signs, Symptoms or Conditions62
- Pain20
- Unspecified Infection14
- Abscess2
- Bone Fracture(s)2
- Numbness2
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 230 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Loss of Osseointegration
InjuryJul 8, 2026Loss of Osseointegration
InjuryJun 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525978 ↗InjuryJun 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525970 ↗InjuryMay 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133090 ↗InjuryMay 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133089 ↗InjuryMay 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133085 ↗InjuryMay 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133080 ↗InjuryApr 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836692 ↗InjuryApr 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836688 ↗InjuryApr 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24786424 ↗InjuryApr 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24786422 ↗InjuryMar 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24657682 ↗InjuryMar 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24657679 ↗InjuryMar 12, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24585888 ↗InjuryMar 12, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24585883 ↗InjuryFeb 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24360515 ↗InjuryFeb 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24360511 ↗InjuryFeb 16, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24357487 ↗InjuryFeb 16, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24357482 ↗InjuryFeb 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24352096 ↗InjuryFeb 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24352093 ↗InjuryJan 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24174722 ↗InjuryJan 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24174719 ↗InjuryJan 22, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24154997 ↗
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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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