NobelZygoma™ 38287 (UDI 07332747161588)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 45° 40mm · 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 228 adverse event reports, including 222 injuries and no deaths. The reports mostly describe the implant failing to bond with the bone, sometimes lacking stability 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
- 229
- Deaths reported
- 0
- Injuries reported
- 223
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 229 adverse event reports that list this exact device (DI 07332747161588), received between Nov 1, 2021 and Aug 20, 2026 — classified as 223 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (135 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 Osseointegrate135
- Osseointegration Problem30
- Loss of Osseointegration28
- Patient Device Interaction Problem12
- Adverse Event Without Identified Device or Use Problem8
- Migration6
- Fracture4
- Activation, Positioning or Separation Problem2
Patient problems
- Failure of Implant162
- No Clinical Signs, Symptoms or Conditions57
- Pain16
- Unspecified Infection16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Numbness3
- Fistula1
Recent adverse event reports
The 25 most recent of 229 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Failure to Osseointegrate
InjuryJun 27, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25647055 ↗InjuryJun 27, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25647053 ↗InjuryJun 11, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25478355 ↗InjuryJun 11, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25478352 ↗InjuryMay 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25154695 ↗InjuryMay 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25154694 ↗InjuryMay 7, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25118514 ↗InjuryMay 7, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25118512 ↗InjuryMay 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25106524 ↗InjuryMay 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25106509 ↗InjuryApr 14, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24878709 ↗InjuryApr 14, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24878705 ↗InjuryApr 11, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24852907 ↗InjuryApr 11, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849046 ↗InjuryApr 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24785967 ↗InjuryApr 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24785965 ↗InjuryMar 10, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24564741 ↗InjuryMar 10, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24564740 ↗InjuryMar 6, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24538774 ↗InjuryMar 6, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24538760 ↗InjuryJan 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24205467 ↗InjuryJan 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24205463 ↗InjuryJan 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24062561 ↗InjuryJan 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24062476 ↗
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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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