NobelReplace® 37289 (UDI 07332747160697)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC NP 3.5x16mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant has 233 adverse event reports, including 230 injuries and no deaths. The reports mostly describe the implant failing to bond with the bone, or later losing that bond, with patients reporting implant failure and pain. 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
- 233
- Deaths reported
- 0
- Injuries reported
- 230
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 07332747160697), received between Nov 17, 2021 and Sep 8, 2026 — classified as 230 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (167 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 Osseointegrate167
- Osseointegration Problem29
- Loss of Osseointegration23
- Fracture7
- Patient Device Interaction Problem3
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
- Malposition of Device1
Patient problems
- Failure of Implant147
- No Clinical Signs, Symptoms or Conditions77
- Pain14
- Unspecified Infection9
- Implant Pain4
- Inflammation4
- Numbness3
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 233 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678754 ↗InjurySep 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678751 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50002129 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50002127 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862623 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862621 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862611 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862608 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25741313 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25741312 ↗InjuryJun 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646873 ↗InjuryJun 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646867 ↗InjuryJun 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646849 ↗InjuryJun 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646842 ↗InjuryJun 19, 2026Failure to Osseointegrate
InjuryJun 19, 2026Failure to Osseointegrate
InjuryMay 28, 2026Failure to Osseointegrate
InjuryMay 28, 2026Failure to Osseointegrate
InjuryMay 23, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25265459 ↗InjuryMay 23, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25265456 ↗InjuryMay 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25195260 ↗InjuryMay 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25195259 ↗InjuryMay 14, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177746 ↗InjuryMay 14, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177740 ↗InjuryMay 14, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177725 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.