NobelActive® 36771 (UDI 07332747037715)Recalls & reported problems

Nobel Biocare AB · NobelActive® 3.0 3.0x13mm · Class 2 · Implant

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

Quick summary

This Nobel Biocare NobelActive implant appears in 662 adverse event reports, with no deaths and 652 injuries. Reports mostly describe the implant failing to fuse with the jawbone or losing that bond, with patients reporting pain and some reporting infection. Reports fell over the last 12 months, to 14 from 68 in the 12 months before, and there are no recalls that 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: 664
Deaths reported: 0
Injuries reported: 654
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 664 adverse event reports that list this exact device (DI 07332747037715), received between Sep 10, 2019 and Sep 30, 2026 — classified as 654 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (304 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

Failure to Osseointegrate304
Loss of Osseointegration284
Adverse Event Without Identified Device or Use Problem30
Osseointegration Problem26
Fracture12
Patient Device Interaction Problem4
Activation, Positioning or Separation Problem2
Difficult to Insert2

Patient problems

Failure of Implant612
Pain87
No Clinical Signs, Symptoms or Conditions44
Unspecified Infection37
Numbness7
Bone Fracture(s)2
Fistula2
Implant Pain2

Recent adverse event reports

The 25 most recent of 664 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954023 ↗
InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954022 ↗
InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Implant Pain
MAUDE report 50215496 ↗
InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Implant Pain
MAUDE report 50215495 ↗
InjuryMay 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25194369 ↗
InjuryMay 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25193427 ↗
InjuryJan 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24205190 ↗
InjuryJan 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24205171 ↗
InjuryJan 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24155913 ↗
InjuryJan 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24155258 ↗
InjuryJan 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24061989 ↗
InjuryJan 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24061988 ↗
InjuryDec 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23844245 ↗
InjuryDec 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23844240 ↗
InjuryDec 2, 2025Osseointegration Problem; Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23699844 ↗
InjuryDec 2, 2025Osseointegration Problem; Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23699838 ↗
InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23443879 ↗
InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23443875 ↗
InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23443583 ↗
InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23443582 ↗
InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420051 ↗
InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420038 ↗
InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420035 ↗
InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420026 ↗
InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23409596 ↗

Device details

UDI-DI	`07332747037715`
Brand	NobelActive®
Model	36771
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.

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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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