NobelReplace® 36712 (UDI 07332747160574)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection RP 5.0x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant is placed into bone. Most of the 1,276 reports describe the implant losing its bond with the bone, and some mention infection. The reports record 1,259 injuries and no deaths. 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
- 1,303
- Deaths reported
- 0
- Injuries reported
- 1,286
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,303 adverse event reports that list this exact device (DI 07332747160574), received between Nov 3, 2021 and Sep 27, 2026 — classified as 1,286 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (822 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 Osseointegrate822
- Loss of Osseointegration329
- Osseointegration Problem71
- Patient Device Interaction Problem28
- Adverse Event Without Identified Device or Use Problem18
- Fracture12
- Migration9
- Premature Separation3
Patient problems
- Failure of Implant730
- No Clinical Signs, Symptoms or Conditions427
- Unspecified Infection129
- Pain58
- Abscess25
- Implant Pain20
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
- Inflammation13
Recent adverse event reports
The 25 most recent of 1,303 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910445 ↗InjurySep 27, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910439 ↗InjurySep 27, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910432 ↗InjurySep 27, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910429 ↗InjurySep 18, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830651 ↗InjurySep 18, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830650 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811808 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811803 ↗InjurySep 14, 2026Loss of Osseointegration
InjurySep 14, 2026Loss of Osseointegration
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50743821 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50743818 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724170 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724169 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724124 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724123 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724122 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724119 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50723888 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50723882 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701161 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701156 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50701129 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50701126 ↗InjurySep 8, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678291 ↗
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.