Brånemark System® 28886Recalls & reported problems

Nobel Biocare AB · Brånemark System Mk III RP 3.75x11.5mm · Class 2 · Implant

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

Adverse event reports: 22
Deaths reported: 0
Injuries reported: 21
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07332747004700), received between Sep 15, 2019 and Nov 12, 2025 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (10 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 Osseointegration10
Failure to Osseointegrate8
Fracture2
Material Integrity Problem2

Patient problems

Failure of Implant16
No Clinical Signs, Symptoms or Conditions4
Pain4
Unspecified Infection4
Numbness2

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 12, 2025Material Integrity Problem; Material Integrity Problem
SURFACE DEFECT ON COMPONENT.
Patient problems: Numbness
MAUDE report 23537840 ↗
InjuryNov 12, 2025Material Integrity Problem; Material Integrity Problem
SURFACE DEFECT ON COMPONENT.
Patient problems: Numbness
MAUDE report 23537824 ↗
InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078944 ↗
InjurySep 17, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078933 ↗
InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078926 ↗
InjurySep 17, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078914 ↗
InjuryMar 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16621927 ↗
InjuryMar 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16621849 ↗
InjuryDec 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 15935166 ↗
InjuryDec 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 15934830 ↗
InjuryFeb 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13580052 ↗
InjuryFeb 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13580043 ↗
InjuryFeb 8, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13484657 ↗
InjuryFeb 8, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13484647 ↗
InjuryJan 11, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 13231494 ↗
InjuryJan 11, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 13231216 ↗
InjurySep 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9067657 ↗
InjurySep 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9067613 ↗
InjurySep 15, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 9067609 ↗
InjurySep 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9063985 ↗
InjurySep 15, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 9063973 ↗
InjurySep 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9063972 ↗

Device details

UDI-DI	`07332747004700`
Brand	Brånemark System®
Model	28886
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	Sep 28, 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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