NobelReplace® 36898Recalls & reported problems
Nobel Biocare AB · NobelReplace PS RP 5.0x11.5mm · Class 2 · Implant
All models of NobelReplace (120)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace dental implant has 94 reports, all describing injuries, and no deaths. Most reports describe the implant failing to bond with the jawbone, and some mention infection, pain, and fractured parts. 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
- 94
- Deaths reported
- 0
- Injuries reported
- 94
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 07332747034073), received between Sep 14, 2019 and Jun 30, 2026 — classified as 94 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (74 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration74
- Failure to Osseointegrate16
- Fracture4
Patient problems
- Failure of Implant72
- Unspecified Infection16
- Pain14
- No Clinical Signs, Symptoms or Conditions10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Implant Pain2
- Inflammation2
- Numbness2
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25671916 ↗InjuryJun 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25671914 ↗InjuryJun 4, 2026Loss of Osseointegration
InjuryJun 4, 2026Loss of Osseointegration
InjuryJun 4, 2026Loss of Osseointegration
InjuryJun 4, 2026Loss of Osseointegration
InjuryApr 11, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24848984 ↗InjuryApr 10, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24841429 ↗InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810140 ↗InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810031 ↗InjuryApr 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24785787 ↗InjuryApr 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24785782 ↗InjuryMar 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24501910 ↗InjuryMar 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24501885 ↗InjuryAug 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22799719 ↗InjuryAug 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22799717 ↗InjuryJul 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22486177 ↗InjuryJul 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22486173 ↗InjuryMar 22, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21672761 ↗InjuryMar 22, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21672758 ↗InjuryDec 4, 2024Loss of Osseointegration; Loss of Osseointegration
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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