NobelReplace® 37297 (UDI 07332747160772)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC RP 5.0x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace bone implant has 758 reports, with no deaths and 750 injuries. Most reports describe the implant failing to bond with the bone, and others describe bonds that were lost later. 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
- 772
- Deaths reported
- 0
- Injuries reported
- 764
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 772 adverse event reports that list this exact device (DI 07332747160772), received between Oct 29, 2021 and Sep 17, 2026 — classified as 764 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (590 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 Osseointegrate590
- Loss of Osseointegration109
- Osseointegration Problem43
- Adverse Event Without Identified Device or Use Problem9
- Migration5
- Patient Device Interaction Problem5
- Premature Separation3
- Activation, Positioning or Separation Problem2
Patient problems
- Failure of Implant440
- No Clinical Signs, Symptoms or Conditions254
- Unspecified Infection71
- Pain31
- Inflammation16
- Numbness14
- Abscess9
- Implant Pain8
Recent adverse event reports
The 25 most recent of 772 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50812063 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50812062 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795761 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795758 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795232 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795224 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724255 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724254 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50699861 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50699859 ↗InjurySep 8, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678731 ↗InjurySep 8, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678717 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50357198 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50357196 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228374 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228366 ↗InjuryAug 7, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183484 ↗InjuryAug 7, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183481 ↗InjuryAug 7, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183455 ↗InjuryAug 7, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183454 ↗InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166326 ↗InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166323 ↗InjuryJul 31, 2026Failure to Osseointegrate
Failure to osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50106020 ↗InjuryJul 31, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50106019 ↗InjuryJul 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25806805 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.