Replace Select™ 36286 (UDI 07332747160383)Recalls & reported problems
Nobel Biocare AB · Replace Select™ TC NP 3.5x(10+3)mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant has 234 adverse event reports, including 221 injuries and no deaths. The reports mostly describe the implant failing to bond with the bone, with some noting it loosening or separating, and patients reporting implant failure, pain, or infection. 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
- 234
- Deaths reported
- 0
- Injuries reported
- 221
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 234 adverse event reports that list this exact device (DI 07332747160383), received between Nov 15, 2021 and Jul 9, 2026 — classified as 221 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (130 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 Osseointegrate130
- Loss of Osseointegration60
- Premature Separation16
- Osseointegration Problem12
- Fracture8
- Adverse Event Without Identified Device or Use Problem6
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant152
- No Clinical Signs, Symptoms or Conditions52
- Pain32
- Unspecified Infection30
- Numbness6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Bone Fracture(s)4
- Fistula4
Recent adverse event reports
The 25 most recent of 234 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Loss of Osseointegration
InjuryJul 9, 2026Loss of Osseointegration
InjuryJul 9, 2026Loss of Osseointegration
InjuryJul 9, 2026Loss of Osseointegration
InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629520 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629518 ↗InjuryJun 25, 2026Loss of Osseointegration
InjuryJun 25, 2026Loss of Osseointegration
InjuryJun 10, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464047 ↗InjuryJun 10, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464037 ↗InjuryMay 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061494 ↗InjuryMay 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061487 ↗InjuryMay 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061485 ↗InjuryMay 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061482 ↗InjuryMar 31, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748301 ↗InjuryMar 31, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748299 ↗InjuryMar 30, 2026Failure to Osseointegrate
InjuryMar 30, 2026Failure to Osseointegrate
InjuryMar 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24538538 ↗InjuryMar 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24538438 ↗InjuryFeb 24, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24435744 ↗InjuryFeb 24, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24435733 ↗InjuryFeb 24, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24435713 ↗InjuryFeb 24, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24435700 ↗InjuryFeb 24, 2026Loss of Osseointegration
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.