Replace Select™ 37303 (UDI 07332747160833)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC NP 3.5x13mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant has 520 adverse event reports, with no deaths and 513 injuries. Many reports describe the implant failing to bond with the bone, and some mention infection, pain and numbness. 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
- 526
- Deaths reported
- 0
- Injuries reported
- 519
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 526 adverse event reports that list this exact device (DI 07332747160833), received between Nov 7, 2021 and Sep 18, 2026 — classified as 519 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (352 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 Osseointegrate352
- Loss of Osseointegration100
- Osseointegration Problem40
- Fracture10
- Adverse Event Without Identified Device or Use Problem6
- Insufficient Device Problem Information4
- Patient Device Interaction Problem4
- Device Markings/Labelling Problem2
Patient problems
- Failure of Implant412
- No Clinical Signs, Symptoms or Conditions78
- Pain66
- Unspecified Infection56
- Numbness14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Insufficient Information4
- Inflammation2
Recent adverse event reports
The 25 most recent of 526 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830294 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830293 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723684 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723657 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723647 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723645 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50679072 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50679065 ↗InjuryAug 25, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441260 ↗InjuryAug 25, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441258 ↗InjuryAug 25, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441215 ↗InjuryAug 25, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441206 ↗InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026870 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026847 ↗InjuryJun 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25643649 ↗InjuryJun 26, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25643643 ↗InjuryJun 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464425 ↗InjuryJun 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464423 ↗InjuryMay 29, 2026Loss of Osseointegration
InjuryMay 29, 2026Loss of Osseointegration
InjuryMay 26, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25289038 ↗InjuryMay 26, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25288472 ↗InjuryApr 8, 2026Loss of Osseointegration
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.