Brånemark System® 28938Recalls & reported problems

Nobel Biocare AB · Brånemark System® Mk IV TiU RP 4.0x18mm · Class 2 · Implant

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

Adverse event reports: 20
Deaths reported: 0
Injuries reported: 20
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07332747013269), received between Nov 2, 2021 and Mar 12, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (16 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 Osseointegration16
Fracture2
Osseointegration Problem2

Patient problems

Failure of Implant16
Pain4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Implant Pain2
No Clinical Signs, Symptoms or Conditions2
Unspecified Infection2

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

InjuryMar 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24585814 ↗
InjuryMar 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24585810 ↗
InjuryJul 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22442842 ↗
InjuryJul 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22442793 ↗
InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 21768741 ↗
InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 21768729 ↗
InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19765522 ↗
InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19765489 ↗
InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19765481 ↗
InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19765438 ↗
InjuryApr 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19092319 ↗
InjuryApr 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19092161 ↗
InjuryAug 10, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15203352 ↗
InjuryAug 10, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15203237 ↗
InjuryAug 10, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15203177 ↗
InjuryAug 10, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15203139 ↗
InjuryJun 10, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 14657577 ↗
InjuryJun 10, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 14657556 ↗
InjuryNov 2, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 12740590 ↗
InjuryNov 2, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 12740572 ↗

Device details

UDI-DI	`07332747013269`
Brand	Brånemark System®
Model	28938
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	Dec 17, 2020

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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