Brånemark System® 28885 (UDI 07332747004694)Recalls & reported problems

Nobel Biocare AB · Brånemark System® Mk III RP 3.75x10mm · Class 2 · Implant

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

Quick summary

This Nobel Biocare Brånemark System dental implant, a root-form endosseous implant, has 60 adverse event reports. Most describe the implant not fusing properly with the jawbone or losing that fusion, so it fails and has to be dealt with, along with reports of pain, infection and abscess. All 60 reports involved injuries, and no deaths were reported. There are no recalls naming 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: 60
Deaths reported: 0
Injuries reported: 60
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 07332747004694), received between Sep 11, 2019 and Apr 9, 2024 — classified as 60 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. 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 Osseointegration29
Failure to Osseointegrate16
Osseointegration Problem7
Fracture4
Adverse Event Without Identified Device or Use Problem2
Insufficient Device Problem Information2

Patient problems

Failure of Implant58
Pain4
Unspecified Infection4
Abscess2
Insufficient Information2
Numbness2

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IMPLANT FAILED DUE TO ABCESS.
Patient problems: Abscess; Failure of Implant
MAUDE report 19074277 ↗
InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IMPLANT FAILED DUE TO ABCESS.
Patient problems: Abscess; Failure of Implant
MAUDE report 19074276 ↗
InjuryMar 15, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18917644 ↗
InjuryMar 15, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18917632 ↗
InjurySep 5, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17685212 ↗
InjurySep 5, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17685211 ↗
InjurySep 5, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 17685185 ↗
InjurySep 5, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 17685159 ↗
InjuryJun 22, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17185988 ↗
InjuryJun 22, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17185985 ↗
InjuryJun 13, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17120835 ↗
InjuryJun 13, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17120824 ↗
InjuryJun 9, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17099790 ↗
InjuryJun 9, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17099766 ↗
InjuryJun 9, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17099752 ↗
InjuryJun 9, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17099735 ↗
InjuryMay 24, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16995564 ↗
InjuryMay 24, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16995538 ↗
InjuryMar 15, 2023Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 16548547 ↗
InjuryMar 15, 2023Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 16548537 ↗
InjuryMar 15, 2023Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 16548515 ↗
InjuryMar 15, 2023Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 16548510 ↗
InjuryFeb 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16374602 ↗
InjuryFeb 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16374568 ↗
InjuryDec 15, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15991324 ↗

Device details

UDI-DI	`07332747004694`
Brand	Brånemark System®
Model	28885
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	Jun 5, 2024

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

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® 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 SLA Titanium BL
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25,298 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
23,448 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
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22,320 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
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22,267 reports

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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