Replace Select™ 36291 (UDI 07332747160437)Recalls & reported problems
Nobel Biocare AB · Replace Select™ TC RP 4.0x(13+3)mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select implant has 195 reports, 192 injuries and no deaths. Nearly all describe the implant failing to bond with the surrounding bone, and some describe 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
- 198
- Deaths reported
- 0
- Injuries reported
- 195
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 07332747160437), received between Nov 7, 2021 and Sep 8, 2026 — classified as 195 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (137 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 Osseointegrate137
- Loss of Osseointegration39
- Osseointegration Problem12
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information2
- Patient Device Interaction Problem2
- Premature Separation2
Patient problems
- Failure of Implant146
- No Clinical Signs, Symptoms or Conditions32
- Pain30
- Unspecified Infection24
- Implant Pain4
- Numbness4
- Inflammation2
Recent adverse event reports
The 25 most recent of 198 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678143 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678141 ↗InjuryJul 31, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50106983 ↗InjuryJul 31, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50106982 ↗InjuryJun 25, 2026Loss of Osseointegration
InjuryJun 25, 2026Loss of Osseointegration
InjuryMay 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25194315 ↗InjuryMay 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25193065 ↗InjuryApr 1, 2026Loss of Osseointegration
InjuryApr 1, 2026Loss of Osseointegration
InjuryMar 31, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748476 ↗InjuryMar 31, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748472 ↗InjuryMar 31, 2026Failure to Osseointegrate
InjuryMar 31, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748406 ↗InjuryMar 31, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748385 ↗InjuryMar 31, 2026Failure to Osseointegrate
InjuryMar 31, 2026Failure to Osseointegrate
InjuryMar 31, 2026Failure to Osseointegrate
InjuryMar 31, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748309 ↗InjuryMar 31, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748307 ↗InjuryMar 31, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748304 ↗InjuryMar 31, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748302 ↗InjuryFeb 20, 2026Loss of Osseointegration
InjuryFeb 20, 2026Loss of Osseointegration
InjuryDec 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.