NobelReplace® 36709 (UDI 07332747160543)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection RP 4.3x16mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is a post set in the jawbone to anchor a replacement tooth. The 310 reports mostly describe the implant failing to bond with the bone and lacking stability when placed, with some reports of infection. There are no deaths and 306 injuries reported, and no recalls name this device. Reports dropped from 106 in the year before to 58 in the latest year.
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
- 312
- Deaths reported
- 0
- Injuries reported
- 308
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 07332747160543), received between Nov 8, 2021 and Sep 11, 2026 — classified as 308 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (188 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
Most reported problems
Device problems
- Failure to Osseointegrate188
- Loss of Osseointegration60
- Osseointegration Problem53
- Adverse Event Without Identified Device or Use Problem5
- Fracture2
- Activation, Positioning or Separation Problem1
- Device Markings/Labelling Problem1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant201
- No Clinical Signs, Symptoms or Conditions98
- Unspecified Infection21
- Pain10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Bone Fracture(s)2
- Numbness2
- Inflammation1
Recent adverse event reports
The 25 most recent of 312 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743126 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743105 ↗InjuryAug 22, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50392633 ↗InjuryAug 8, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187824 ↗InjuryAug 8, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187823 ↗InjuryAug 8, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187631 ↗InjuryAug 8, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187629 ↗InjuryAug 8, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187621 ↗InjuryAug 8, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187620 ↗InjuryAug 5, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149677 ↗InjuryJul 17, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862852 ↗InjuryJul 17, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862851 ↗InjuryJul 17, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862794 ↗InjuryJul 17, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862785 ↗InjuryJul 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848545 ↗InjuryJul 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848524 ↗InjuryJul 15, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832949 ↗InjuryJul 15, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832943 ↗InjuryJul 4, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711432 ↗InjuryJul 4, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711430 ↗InjuryJul 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25707978 ↗InjuryJul 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25707972 ↗InjuryJul 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683236 ↗InjuryJul 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683234 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629620 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.