Brånemark System® 34737 (UDI 07332747013498)Recalls & reported problems

Nobel Biocare AB · Brånemark System® Zygoma TiU 45mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This is a Nobel Biocare Brånemark System dental implant used to anchor replacement teeth in the jawbone. Most of the 63 reports describe the implant failing to bond with the surrounding bone, or losing that bond after surgery, along with pain, numbness and sinus problems; there are 63 injuries and no deaths. Two reports also mention a fractured implant. 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: 63
Deaths reported: 0
Injuries reported: 63
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 07332747013498), received between Sep 11, 2019 and Feb 16, 2026 — classified as 63 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (29 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

Failure to Osseointegrate29
Loss of Osseointegration28
Osseointegration Problem4
Fracture2

Patient problems

Failure of Implant59
Pain13
Unspecified Infection8
Numbness4
Abscess2
No Clinical Signs, Symptoms or Conditions2
Sinus Perforation2

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess
MAUDE report 24358953 ↗
InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Abscess
MAUDE report 24358925 ↗
InjuryDec 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929617 ↗
InjuryDec 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929581 ↗
InjuryJan 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 21075573 ↗
InjuryJan 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 21075570 ↗
InjuryJan 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 21075559 ↗
InjuryJan 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 21075557 ↗
InjuryJan 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 21075555 ↗
InjuryJan 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 21075552 ↗
InjuryApr 25, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19186574 ↗
InjuryApr 25, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19186572 ↗
InjuryDec 15, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18340280 ↗
InjuryDec 15, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18340194 ↗
InjuryMay 4, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16871322 ↗
InjuryMay 4, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16871300 ↗
InjuryMay 2, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 16857169 ↗
InjuryMay 2, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 16855418 ↗
InjuryMar 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16575842 ↗
InjuryMar 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16575830 ↗
InjuryJan 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16151190 ↗
InjuryJan 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16151145 ↗
InjuryNov 16, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 15810493 ↗
InjuryNov 16, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 15808472 ↗
InjuryOct 4, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 15534908 ↗

Device details

UDI-DI	`07332747013498`
Brand	Brånemark System®
Model	34737
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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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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