NobelZygoma™ 38288 (UDI 07332747102789)Recalls & reported problems

Nobel Biocare AB · NobelZygoma™ 45° 42.5mm · Class 2 · Implant

All models of NobelZygoma (36)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This NobelZygoma zygomatic dental implant from Nobel Biocare has 42 adverse event reports, with no deaths and 42 injuries. Reports mostly describe the implant failing to join to the bone or later loosening, with pain, numbness and infection including abscess. No recalls name this device. Reports have risen recently, with 6 in the last 12 months compared with 0 in the prior 12 months.

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: 42
Deaths reported: 0
Injuries reported: 42
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07332747102789), received between Sep 10, 2019 and May 23, 2026 — classified as 42 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (25 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Osseointegrate25
Loss of Osseointegration13
Fracture2
Osseointegration Problem2

Patient problems

Failure of Implant36
Pain14
Numbness5
Abscess4
Unspecified Infection3
Inflammation2
Sinus Perforation2

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

InjuryMay 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inflammation
MAUDE report 25265924 ↗
InjuryMay 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inflammation
MAUDE report 25265916 ↗
InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess
MAUDE report 24358976 ↗
InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 24358972 ↗
InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 24358969 ↗
InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess
MAUDE report 24358958 ↗
InjuryOct 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 17943652 ↗
InjuryOct 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 17943651 ↗
InjuryApr 11, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16716444 ↗
InjuryApr 11, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16716438 ↗
InjuryMar 24, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Sinus Perforation
MAUDE report 16613699 ↗
InjuryMar 24, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Sinus Perforation
MAUDE report 16613696 ↗
InjuryJan 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16235905 ↗
InjuryJan 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16235888 ↗
InjuryJan 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 16228352 ↗
InjuryJan 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 16228340 ↗
InjuryNov 16, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 15809074 ↗
InjuryNov 16, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 15808718 ↗
InjuryOct 17, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 15619699 ↗
InjuryOct 17, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 15619033 ↗
InjuryAug 18, 2022Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 15253237 ↗
InjuryAug 18, 2022Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 15253169 ↗
InjuryJan 19, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 13292016 ↗
InjuryJan 19, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 13291987 ↗
InjuryDec 28, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13100324 ↗

Device details

UDI-DI	`07332747102789`
Brand	NobelZygoma™
Model	38288
Company	Nobel Biocare AB
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Oct 12, 2023

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

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All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

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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