NobelZygoma™ 38284 (UDI 07332747161557)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 45° 32.5mm · 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 100 adverse event reports: no deaths, 97 injuries, and 3 malfunctions. Most reports describe implants failing to bond with bone or losing that bond, sometimes with fractures or material deformation; a few mention pain or infection. 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
- 100
- Deaths reported
- 0
- Injuries reported
- 97
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 07332747161557), received between Nov 8, 2021 and Jul 8, 2026 — classified as 97 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (64 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 Osseointegrate64
- Loss of Osseointegration20
- Insufficient Device Problem Information4
- Material Deformation4
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
- Osseointegration Problem2
- Patient Device Interaction Problem2
Patient problems
- Failure of Implant76
- No Clinical Signs, Symptoms or Conditions16
- Pain6
- Unspecified Infection6
- Abscess2
- Implant Pain2
- Insufficient Information2
- Osteomyelitis2
Recent adverse event reports
The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Loss of Osseointegration
InjuryJul 8, 2026Loss of Osseointegration
InjuryJun 18, 2026Loss of Osseointegration
InjuryJun 18, 2026Loss of Osseointegration
InjuryMay 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25106526 ↗InjuryMay 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25106525 ↗InjuryMay 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088221 ↗InjuryMay 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088219 ↗InjuryApr 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917544 ↗InjuryApr 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917542 ↗InjuryDec 16, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23823071 ↗InjuryDec 16, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23823067 ↗InjuryOct 22, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23363043 ↗InjuryOct 22, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23363042 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23296755 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23295752 ↗InjurySep 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22660779 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22660777 ↗InjuryFeb 5, 2025Osseointegration Problem; Osseointegration Problem
InjuryFeb 5, 2025Osseointegration Problem; Osseointegration Problem
InjuryFeb 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryFeb 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
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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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