Brånemark System® 34740 (UDI 07332747013528)Recalls & reported problems

Nobel Biocare AB · Brånemark System® Zygoma TiU 52.5mm · Class 2 · Implant

Quick summary

This Nobel Biocare Brånemark System zygoma implant is a long dental implant anchored in the cheekbone. Reports mostly describe implants failing to stay joined to bone, sometimes with pain, infection or numbness. There are 24 reports mentioning 24 injuries and no deaths. 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: 24
Deaths reported: 0
Injuries reported: 24
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07332747013528), received between Sep 11, 2019 and Apr 16, 2024 — classified as 24 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (23 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Loss of Osseointegration23
Insufficient Device Problem Information1

Patient problems

Failure of Implant24
Pain7
Unspecified Infection3
Numbness2

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

InjuryApr 16, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19120252 ↗
InjuryApr 16, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19120207 ↗
InjuryNov 15, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15800076 ↗
InjuryNov 15, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15799996 ↗
InjuryJul 20, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15068920 ↗
InjuryJul 20, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15068840 ↗
InjuryJul 12, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14989879 ↗
InjuryJul 12, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14989633 ↗
InjuryMay 25, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14500356 ↗
InjuryMay 25, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14500324 ↗
InjuryMay 25, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14500307 ↗
InjuryMay 25, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14500158 ↗
InjuryMay 19, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14437512 ↗
InjuryMay 19, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14437416 ↗
InjuryNov 11, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 12799616 ↗
InjuryNov 11, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 12799456 ↗
InjuryMar 28, 2020Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 9892796 ↗
InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IMPLANT FAILED DUE TO AN UNCONFIRMED ISSUE.
Patient problems: Failure of Implant
MAUDE report 9456440 ↗
InjurySep 15, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUR TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 9060676 ↗
InjurySep 14, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUR TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 9052124 ↗
InjurySep 14, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 9051692 ↗
InjurySep 13, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 9023980 ↗
InjurySep 11, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 8990205 ↗
InjurySep 11, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 8989050 ↗

Device details

UDI-DI	`07332747013528`
Brand	Brånemark System®
Model	34740
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	Jun 5, 2024

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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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.