NobelReplace® 36844Recalls & reported problems
Nobel Biocare AB · NobelReplace PS NP 4.3x13mm · Class 2 · Implant
All models of NobelReplace (120)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This NobelReplace implant is an endosseous root-form dental implant. Reports mostly describe loss of or failure to osseointegrate, sometimes alongside infection or pain. There are 77 adverse event reports that name it, with no deaths and 77 injuries. 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
- 77
- Deaths reported
- 0
- Injuries reported
- 77
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 07332747034110), received between Nov 30, 2021 and Apr 7, 2026 — classified as 77 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (60 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration60
- Failure to Osseointegrate10
- Osseointegration Problem5
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Failure of Implant57
- Unspecified Infection14
- No Clinical Signs, Symptoms or Conditions10
- Pain8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Abscess2
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810259 ↗InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810164 ↗InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810062 ↗InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810030 ↗InjuryApr 7, 2026Loss of Osseointegration
InjuryApr 7, 2026Loss of Osseointegration
InjuryApr 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24786161 ↗InjuryApr 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24786160 ↗InjuryApr 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24786066 ↗InjuryApr 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24786058 ↗InjuryMar 6, 2026Loss of Osseointegration
InjuryMar 6, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24351165 ↗InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24351162 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22763280 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22763274 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22761655 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22761652 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 29, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 29, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 27, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20801945 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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