Replace Select™ 36104 (UDI 07332747160291)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered TiU NP 3.5x8mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant has 168 reports, with no deaths and 159 injuries. Most reports describe the implant failing to bond with the jawbone, and a smaller number mention infection and pain. 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
- 170
- Deaths reported
- 0
- Injuries reported
- 161
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 07332747160291), received between Nov 11, 2021 and Aug 19, 2026 — classified as 161 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (105 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 Osseointegrate105
- Loss of Osseointegration40
- Adverse Event Without Identified Device or Use Problem7
- Fracture6
- Osseointegration Problem6
- Material Deformation2
- Migration2
- Device Markings/Labelling Problem1
Patient problems
- Failure of Implant125
- No Clinical Signs, Symptoms or Conditions25
- Unspecified Infection14
- Pain11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Numbness3
- Fistula2
- Implant Pain2
Recent adverse event reports
The 25 most recent of 170 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332445 ↗InjuryAug 19, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332444 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229125 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229123 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229122 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229117 ↗InjuryJul 28, 2026Loss of Osseointegration
InjuryJul 28, 2026Loss of Osseointegration
InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061794 ↗InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061792 ↗InjuryJul 17, 2026Failure to Osseointegrate
InjuryJul 17, 2026Failure to Osseointegrate
InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 25741352 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 25741347 ↗InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24823556 ↗InjuryApr 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24823542 ↗InjuryFeb 21, 2026Loss of Osseointegration
InjuryFeb 21, 2026Loss of Osseointegration
InjuryFeb 21, 2026Loss of Osseointegration
InjuryFeb 21, 2026Failure to Osseointegrate
InjuryFeb 21, 2026Loss of Osseointegration
InjuryFeb 21, 2026Failure to Osseointegrate
InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24351001 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.