Replace Select™ 37314 (UDI 07332747160949)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC WP 5.0x16mm · Class 2 · Implant
All models of Replace Select (107)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Replace Select tapered dental implant is a root-form screw placed into the jaw to support a tooth replacement. Most of the 34 reports describe the implant failing to fuse with the surrounding bone, or losing that fusion after healing, so the implant does not hold and the site can become inflamed or painful. There are 33 injuries and no deaths, 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
- 34
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 07332747160949), received between Feb 11, 2022 and Aug 13, 2026 — classified as 33 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (22 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration22
- Failure to Osseointegrate10
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Failure of Implant18
- No Clinical Signs, Symptoms or Conditions14
- Inflammation2
- Pain2
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243457 ↗InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243456 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229350 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229349 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229347 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229346 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50014972 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50014969 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629626 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629624 ↗InjuryMay 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236328 ↗InjuryMay 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236026 ↗InjuryOct 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23385689 ↗InjuryOct 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23385686 ↗InjuryJul 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 10, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19504389 ↗InjuryJun 10, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19504237 ↗InjuryOct 16, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17943467 ↗InjuryOct 16, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17943466 ↗InjuryJul 14, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15018280 ↗InjuryJul 14, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15018254 ↗InjuryApr 20, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 14163032 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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