Brånemark System® 28907 (UDI 07332747001129)Recalls & reported problems

Nobel Biocare AB · Brånemark System® Mk III TiU NP 3.3x11.5mm · Class 2 · Implant

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

Quick summary

This Nobel Biocare Brånemark System dental implant has 110 adverse event reports, with no deaths and 110 injuries. Most reports describe the implant failing to bond with the jawbone or losing that bond. 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: 110
Deaths reported: 0
Injuries reported: 110
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 07332747001129), received between Sep 11, 2019 and Mar 4, 2026 — classified as 110 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (55 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 Osseointegration55
Failure to Osseointegrate33
Osseointegration Problem8
Fracture6
Patient Device Interaction Problem6
Adverse Event Without Identified Device or Use Problem2

Patient problems

Failure of Implant102
Pain27
Unspecified Infection8
No Clinical Signs, Symptoms or Conditions4
Numbness2
Abscess1

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

InjuryMar 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 24514715 ↗
InjuryMar 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 24514295 ↗
InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 22604462 ↗
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 22603525 ↗
InjuryMar 15, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18917409 ↗
InjuryMar 15, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18917405 ↗
InjuryMar 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18917391 ↗
InjuryMar 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18917389 ↗
InjuryMar 7, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18860783 ↗
InjuryMar 7, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18860671 ↗
InjuryFeb 29, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18811535 ↗
InjuryFeb 29, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18811527 ↗
InjuryDec 13, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18321460 ↗
InjuryDec 13, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION
Patient problems: Failure of Implant
MAUDE report 18321457 ↗
InjuryDec 13, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18321453 ↗
InjuryDec 13, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18321452 ↗
InjuryNov 14, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18134557 ↗
InjuryNov 14, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18134552 ↗
InjurySep 7, 2023Fracture; Fracture
IMPLANT FAILED DUE TO PART FRACTURED.
Patient problems: Failure of Implant
MAUDE report 17702097 ↗
InjurySep 7, 2023Fracture; Fracture
IMPLANT FAILED DUE TO PART FRACTURED.
Patient problems: Failure of Implant
MAUDE report 17702092 ↗
InjuryAug 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
THE IMPLANT FAILED DUE TO LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17444755 ↗
InjuryAug 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
THE IMPLANT FAILED DUE TO LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17444724 ↗
InjuryAug 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED DUE TO LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17444723 ↗
InjuryAug 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED DUE TO LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17444718 ↗
InjuryJun 30, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 17241477 ↗

Device details

UDI-DI	`07332747001129`
Brand	Brånemark System®
Model	28907
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 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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