NobelReplace® 32186Recalls & reported problems
Nobel Biocare AB · NOBELREPLACE® Straight Groovy WP 5x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is a screw-shaped device placed into bone. All 186 reports are injuries and there are no deaths. Most describe the implant losing its bond with the surrounding bone, and some mention infection or pain. 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
- 188
- Deaths reported
- 0
- Injuries reported
- 188
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 07332747019131), received between Nov 10, 2021 and Sep 11, 2026 — classified as 188 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (168 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
- Loss of Osseointegration168
- Failure to Osseointegrate10
- Fracture8
- Osseointegration Problem2
Patient problems
- Failure of Implant154
- Unspecified Infection38
- No Clinical Signs, Symptoms or Conditions18
- Pain18
- Abscess2
- Fistula2
Recent adverse event reports
The 25 most recent of 188 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743201 ↗InjurySep 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743197 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026950 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026949 ↗InjuryJul 13, 2026Loss of Osseointegration
InjuryJul 13, 2026Loss of Osseointegration
InjuryJul 1, 2026Loss of Osseointegration
InjuryJul 1, 2026Loss of Osseointegration
InjuryJun 11, 2026Loss of Osseointegration
InjuryJun 11, 2026Loss of Osseointegration
InjuryJun 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464538 ↗InjuryJun 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464532 ↗InjuryJun 9, 2026Loss of Osseointegration
InjuryJun 9, 2026Loss of Osseointegration
InjuryJun 3, 2026Loss of Osseointegration
InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION. THE MATERIAL NUMBER HAS BEEN UPDATED, WHICH IS REFLECTED IN THIS FOLLOW UP REPORT.
Patient problems: Unspecified Infection
MAUDE report 25385221 ↗InjuryApr 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837441 ↗InjuryApr 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837440 ↗InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 3, 2026Loss of Osseointegration
InjuryFeb 3, 2026Loss of Osseointegration
InjuryJan 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24088716 ↗InjuryJan 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24088690 ↗InjuryDec 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23845663 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.