NobelReplace® 37295 (UDI 07332747073546)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC RP 5.0x8mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant has 263 adverse event reports, including 260 injuries, 3 malfunctions and no deaths. Most reports describe the implant failing to bond with the jawbone or losing that bond over time, and some note pain or infection. 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
- 265
- Deaths reported
- 0
- Injuries reported
- 262
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 265 adverse event reports that list this exact device (DI 07332747073546), received between Sep 11, 2019 and Sep 28, 2026 — classified as 262 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (127 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 Osseointegrate127
- Loss of Osseointegration127
- Adverse Event Without Identified Device or Use Problem6
- Osseointegration Problem4
- Fracture1
- Malposition of Device1
Patient problems
- Failure of Implant234
- Unspecified Infection37
- Pain32
- No Clinical Signs, Symptoms or Conditions14
- Numbness3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Inflammation2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 265 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924811 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924810 ↗InjuryJun 30, 2026Loss of Osseointegration
InjuryJun 30, 2026Loss of Osseointegration
InjuryMay 26, 2026Loss of Osseointegration
InjuryMay 26, 2026Loss of Osseointegration
InjuryMay 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25235177 ↗InjuryMay 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25235173 ↗InjuryMay 8, 2026Loss of Osseointegration
InjuryMay 8, 2026Loss of Osseointegration
InjuryMar 12, 2026Loss of Osseointegration
InjuryMar 11, 2026Loss of Osseointegration
InjuryFeb 25, 2026Loss of Osseointegration
InjuryFeb 25, 2026Loss of Osseointegration
InjuryJan 20, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24123851 ↗InjuryJan 20, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24123850 ↗InjuryDec 11, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 11, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23295502 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23294625 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22659727 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22659722 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22599746 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.