NobelReplace® 36842Recalls & reported problems
Nobel Biocare AB · NobelReplace PS NP 4.3x10mm · Class 2 · Implant
Quick summary
This NobelReplace dental implant is a root-form implant placed into bone. Most of the 124 reports describe the implant losing its bond with the bone, and some describe infection or pain around the implant. The reports include no deaths and 123 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
- 124
- Deaths reported
- 0
- Injuries reported
- 123
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 07332747034134), received between Sep 13, 2019 and Aug 11, 2026 — classified as 123 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (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
- Loss of Osseointegration106
- Adverse Event Without Identified Device or Use Problem6
- Failure to Osseointegrate6
- Activation, Positioning or Separation Problem2
- Fracture2
- Patient Device Interaction Problem2
Patient problems
- Failure of Implant86
- Unspecified Infection18
- No Clinical Signs, Symptoms or Conditions16
- Implant Pain10
- Pain8
- Abscess6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Inflammation2
Recent adverse event reports
The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215369 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215365 ↗InjuryJul 3, 2026Loss of Osseointegration
InjuryJul 3, 2026Loss of Osseointegration
InjuryApr 14, 2026Loss of Osseointegration
InjuryApr 14, 2026Loss of Osseointegration
InjuryMar 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24514525 ↗InjuryMar 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24514130 ↗InjuryJan 12, 2026Loss of Osseointegration
InjuryJan 12, 2026Loss of Osseointegration
InjuryDec 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23676463 ↗InjuryNov 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23676461 ↗InjuryNov 27, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 27, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23432453 ↗InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23432435 ↗InjurySep 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23101375 ↗InjurySep 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23101365 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22615350 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22614364 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.