NobelReplace® 36701 (UDI 07332747160475)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection NP 3.5x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant is placed in the jawbone. The reports mostly describe implants that failed to bond with the bone, with some also mentioning infection or pain. FDA records list 5,585 reports, no deaths, 5,510 injuries and 75 malfunctions. 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
- 5,618
- Deaths reported
- 0
- Injuries reported
- 5,543
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5,618 adverse event reports that list this exact device (DI 07332747160475), received between Oct 29, 2021 and Sep 28, 2026 — classified as 5,543 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4,106 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 Osseointegrate4,106
- Loss of Osseointegration873
- Osseointegration Problem250
- Fracture104
- Adverse Event Without Identified Device or Use Problem95
- Patient Device Interaction Problem62
- Migration38
- Activation, Positioning or Separation Problem20
Patient problems
- Failure of Implant3,729
- No Clinical Signs, Symptoms or Conditions1,449
- Unspecified Infection400
- Pain379
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available92
- Abscess77
- Numbness66
- Inflammation52
Recent adverse event reports
The 25 most recent of 5,618 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924864 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924863 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832782 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832781 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830833 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830825 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50830759 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50830757 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830724 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830722 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829915 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829912 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811510 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811504 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50811191 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50811189 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810523 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810522 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795192 ↗InjurySep 16, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795189 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50781433 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50781431 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781428 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50781427 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781426 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.