Brånemark System® 28923 (UDI 07332747001273)Recalls & reported problems

Nobel Biocare AB · Brånemark System® Mk III TiU RP 4.0x15mm · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Nobel Biocare Brånemark System implant is a tooth implant placed in the jawbone. Its 104 reports, all injury reports, mostly describe the implant failing to fuse with the bone, and a few describe a screw breaking inside the implant. Some patients reported pain or infection. There were no deaths, and 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: 104
Deaths reported: 0
Injuries reported: 104
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 07332747001273), received between Sep 11, 2019 and Jun 24, 2024 — classified as 104 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (69 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Loss of Osseointegration69
Failure to Osseointegrate26
Fracture3
Adverse Event Without Identified Device or Use Problem2
Device Damaged by Another Device2
Osseointegration Problem2

Patient problems

Failure of Implant104
Pain26
Unspecified Infection25
Numbness5

Recent adverse event reports

The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

InjuryJun 24, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19600343 ↗
InjuryJun 24, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19599928 ↗
InjuryMay 14, 2024Device Damaged by Another Device; Device Damaged by Another Device
IMPLANT FAILED DUE TO SCREW BROKE OFF IN IMPLANT.
Patient problems: Failure of Implant; Pain
MAUDE report 19313778 ↗
InjuryMay 14, 2024Device Damaged by Another Device; Device Damaged by Another Device
IMPLANT FAILED DUE TO SCREW BROKE OFF IN IMPLANT.
Patient problems: Failure of Implant; Pain
MAUDE report 19313731 ↗
InjuryMay 6, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19254586 ↗
InjuryMay 6, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19254572 ↗
InjuryMar 5, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18841121 ↗
InjuryMar 5, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18840636 ↗
InjuryJan 25, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18583783 ↗
InjuryJan 25, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18582872 ↗
InjuryDec 19, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 18359355 ↗
InjuryDec 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 18359312 ↗
InjuryDec 19, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 18359307 ↗
InjuryDec 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 18359294 ↗
InjuryDec 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 18359274 ↗
InjuryDec 19, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 18359263 ↗
InjuryDec 19, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 18359171 ↗
InjuryDec 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 18359164 ↗
InjuryDec 1, 2023Fracture; Fracture
IMPLANT FAILED DUE TO PART FRACTURED
Patient problems: Failure of Implant
MAUDE report 18249729 ↗
InjuryDec 1, 2023Fracture; Fracture
IMPLANT FAILED DUE TO PART FRACTURED.
Patient problems: Failure of Implant
MAUDE report 18249726 ↗
InjuryNov 16, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18153762 ↗
InjuryNov 16, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION
Patient problems: Failure of Implant
MAUDE report 18153760 ↗
InjuryOct 20, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17979541 ↗
InjuryOct 20, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17979512 ↗
InjuryOct 20, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17979482 ↗

Device details

UDI-DI	`07332747001273`
Brand	Brånemark System®
Model	28923
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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Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
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STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BL
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Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
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STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
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STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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