Brånemark System® 28909 (UDI 07332747001143)Recalls & reported problems

Nobel Biocare AB · Brånemark System® Mk III TiU NP 3.3x15mm · Class 2 · Implant

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

Quick summary

This Nobel Biocare Brånemark dental implant is a small screw-shaped fixture placed in the jawbone to anchor a replacement tooth. The 39 reports mostly describe implants that fail to fuse with the surrounding bone, so the implant loses its grip and has to be removed; patients also mention pain, abscesses, infection, and numbness. All 39 reports involve injuries, with 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: 39
Deaths reported: 0
Injuries reported: 39
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07332747001143), received between Sep 13, 2019 and Jul 29, 2025 — classified as 39 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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

Loss of Osseointegration29
Failure to Osseointegrate4
Fracture2
Malposition of Device2
Osseointegration Problem2

Patient problems

Failure of Implant31
Abscess8
Pain8
Numbness6
Unspecified Infection6

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22655278 ↗
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22655276 ↗
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22655259 ↗
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22655256 ↗
InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: Abscess
MAUDE report 22617849 ↗
InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22617848 ↗
InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22617802 ↗
InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Abscess
MAUDE report 22617797 ↗
InjuryJun 27, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17212789 ↗
InjuryJun 27, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17212784 ↗
InjuryJun 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17185677 ↗
InjuryJun 22, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17185670 ↗
InjuryJun 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17185661 ↗
InjuryJun 22, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17185658 ↗
InjuryJun 7, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17082863 ↗
InjuryJun 7, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17082780 ↗
InjuryFeb 10, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant; Pain
MAUDE report 16356547 ↗
InjuryFeb 10, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant; Pain
MAUDE report 16356531 ↗
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness
MAUDE report 16299336 ↗
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness
MAUDE report 16299234 ↗
InjuryDec 5, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15919610 ↗
InjuryDec 5, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15919474 ↗
InjuryNov 7, 2022Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant; Numbness
MAUDE report 15748992 ↗
InjuryNov 7, 2022Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant; Numbness
MAUDE report 15748985 ↗
InjuryJul 8, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 14960469 ↗

Device details

UDI-DI	`07332747001143`
Brand	Brånemark System®
Model	28909
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.

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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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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