NobelReplace® 37288 (UDI 07332747160680)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC NP 3.5x13mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is a screw placed in the jawbone to hold a replacement tooth. Of its 1,707 reports, 1,681 involve an injury, and most describe the implant failing to fuse with the bone or later losing that bond. Some describe a lack of stability during placement, and some mention infection and pain. There are no deaths reported, and 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
- 1,725
- Deaths reported
- 0
- Injuries reported
- 1,699
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,725 adverse event reports that list this exact device (DI 07332747160680), received between Nov 3, 2021 and Sep 17, 2026 — classified as 1,699 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,379 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 Osseointegrate1,379
- Loss of Osseointegration169
- Osseointegration Problem91
- Adverse Event Without Identified Device or Use Problem19
- Patient Device Interaction Problem19
- Fracture18
- Migration12
- Premature Separation6
Patient problems
- Failure of Implant1,023
- No Clinical Signs, Symptoms or Conditions512
- Unspecified Infection205
- Pain113
- Numbness28
- Inflammation26
- Fistula25
- Abscess18
Recent adverse event reports
The 25 most recent of 1,725 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811718 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811716 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810494 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810492 ↗InjurySep 16, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796087 ↗InjurySep 16, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796084 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50743033 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50743032 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50743031 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50743015 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700684 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700683 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678049 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678048 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487066 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487065 ↗InjuryAug 27, 2026Osseointegration Problem
Lack of stability during placement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486333 ↗InjuryAug 27, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486330 ↗InjuryAug 27, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50485408 ↗InjuryAug 27, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50485406 ↗InjuryAug 25, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441130 ↗InjuryAug 25, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441127 ↗InjuryAug 21, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50381630 ↗InjuryAug 19, 2026Failure to Osseointegrate
InjuryAug 19, 2026Failure to Osseointegrate
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.