Brånemark System® 28917 (UDI 07332747001211)Recalls & reported problems

Nobel Biocare AB · Brånemark System® Mk III TiU RP 3.75x18mm · Class 2 · Implant

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

Quick summary

This Nobel Biocare Brånemark dental implant is a screw-shaped titanium post used as a root for a replacement tooth. The 48 reports describe implants that did not fuse with the jawbone and had to be removed, along with pain, numbness, and infection; a few also mention the implant breaking or sitting in the wrong spot. There are 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: 48
Deaths reported: 0
Injuries reported: 48
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07332747001211), received between Feb 3, 2020 and Apr 17, 2024 — classified as 48 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (38 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 Osseointegration38
Fracture4
Malposition of Device4
Failure to Osseointegrate2

Patient problems

Failure of Implant48
Pain22
Unspecified Infection10
Numbness8

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19128787 ↗
InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19128675 ↗
InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19128651 ↗
InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19128646 ↗
InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19128572 ↗
InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19128563 ↗
InjuryDec 4, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18259787 ↗
InjuryDec 4, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18259755 ↗
InjuryJul 19, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 17355587 ↗
InjuryJul 19, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 17355578 ↗
InjuryJul 19, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 17355141 ↗
InjuryJul 19, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 17355139 ↗
InjuryJul 5, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 17258111 ↗
InjuryJul 5, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION
Patient problems: Failure of Implant; Pain
MAUDE report 17257539 ↗
InjuryFeb 22, 2023Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 16420044 ↗
InjuryFeb 22, 2023Fracture; Fracture
IMPLANT FAILED DUE TO A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 16420028 ↗
InjuryJan 9, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain; Unspecified Infection
MAUDE report 16125112 ↗
InjuryJan 9, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain; Unspecified Infection
MAUDE report 16123885 ↗
InjuryJan 9, 2023Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 16123731 ↗
InjuryJan 9, 2023Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 16123682 ↗
InjuryNov 29, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 15881872 ↗
InjuryNov 29, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 15881705 ↗
InjuryNov 28, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15874207 ↗
InjuryNov 28, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15873862 ↗
InjuryNov 2, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 15717343 ↗

Device details

UDI-DI	`07332747001211`
Brand	Brånemark System®
Model	28917
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 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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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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