NobelReplace® 36703 (UDI 07332747160499)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection NP 3.5x16mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant is a post placed in the jawbone to hold a tooth replacement. Its 335 reports mostly describe the implant failing to bond with the jawbone, sometimes lacking stability after placement. The reports mention 326 injuries and no deaths. 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
- 339
- Deaths reported
- 0
- Injuries reported
- 330
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 339 adverse event reports that list this exact device (DI 07332747160499), received between Nov 4, 2021 and Sep 29, 2026 — classified as 330 injuries, 9 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 Osseointegration79
- Osseointegration Problem49
- Adverse Event Without Identified Device or Use Problem8
- Migration5
- Patient Device Interaction Problem5
- Delivered as Unsterile Product2
- Device Markings/Labelling Problem2
Patient problems
- Failure of Implant183
- No Clinical Signs, Symptoms or Conditions144
- Pain12
- Unspecified Infection10
- Fistula6
- Numbness4
- Abscess2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 339 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940604 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940601 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939507 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939504 ↗InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263231 ↗InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263229 ↗InjuryAug 13, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243119 ↗InjuryAug 13, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243117 ↗InjuryAug 8, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187626 ↗InjuryAug 8, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187619 ↗InjuryJul 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25849169 ↗InjuryJul 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25849158 ↗InjuryJul 15, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832298 ↗InjuryJul 15, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832186 ↗InjuryJul 13, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805744 ↗InjuryJul 13, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805742 ↗InjuryJun 30, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25672365 ↗InjuryJun 30, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25672364 ↗InjuryJun 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25671270 ↗InjuryJun 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25671269 ↗InjuryJun 25, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25628454 ↗InjuryJun 25, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25628445 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25385371 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25385370 ↗InjuryMay 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088183 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.