NobelReplace® 32214Recalls & reported problems
Nobel Biocare AB · NobelReplace® Tapered Groovy NP 3.5x16mm · Class 2 · Implant
All models of NobelReplace (120)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace dental implant has 212 adverse event reports, with no deaths and 211 injuries. Most describe the implant losing or never achieving a bond with the jawbone, and some mention pain, infection and numbness. 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
- 212
- Deaths reported
- 0
- Injuries reported
- 211
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 07332747001822), received between Sep 12, 2019 and Aug 12, 2026 — classified as 211 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (158 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
Most reported problems
Device problems
- Loss of Osseointegration158
- Failure to Osseointegrate46
- Osseointegration Problem4
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
Patient problems
- Failure of Implant185
- Pain40
- Unspecified Infection32
- No Clinical Signs, Symptoms or Conditions21
- Numbness10
Recent adverse event reports
The 25 most recent of 212 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228617 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228616 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228613 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228612 ↗InjuryJul 30, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50091617 ↗InjuryApr 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973756 ↗InjuryApr 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972941 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24623302 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24623296 ↗InjuryJan 30, 2026Loss of Osseointegration
InjuryJan 30, 2026Loss of Osseointegration
InjuryDec 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23917716 ↗InjuryDec 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23917710 ↗InjuryDec 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23893597 ↗InjuryDec 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23893593 ↗InjuryDec 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23893589 ↗InjuryDec 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23893587 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 22, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22878571 ↗InjuryAug 22, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22878570 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22762477 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22762475 ↗InjuryAug 8, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22761541 ↗InjuryAug 8, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22761537 ↗
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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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