Replace Select™ 37307 (UDI 07332747073423)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC RP 4.3x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant is a screw-shaped post placed in the jawbone to hold a replacement tooth. Most of the 292 reports describe the implant losing or never gaining its bond with the bone, and some describe pain, infection or an abscess. The number of reports fell from 18 in the prior 12 months to 6 in the last 12 months. The reports include no deaths and 289 injuries. 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
- 292
- Deaths reported
- 0
- Injuries reported
- 289
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 292 adverse event reports that list this exact device (DI 07332747073423), received between Sep 11, 2019 and Aug 12, 2026 — classified as 289 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (147 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
- Loss of Osseointegration147
- Failure to Osseointegrate92
- Osseointegration Problem41
- Fracture6
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant279
- Pain50
- Unspecified Infection38
- Numbness10
- No Clinical Signs, Symptoms or Conditions9
- Abscess6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 292 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228553 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228547 ↗InjuryFeb 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24263735 ↗InjuryFeb 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24263733 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 23675298 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 23675294 ↗InjuryAug 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928643 ↗InjuryAug 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928616 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21768345 ↗InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21768336 ↗InjuryMar 15, 2025Fracture; Fracture
InjuryMar 15, 2025Fracture; Fracture
InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 14, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 14, 2024Loss of Osseointegration; Loss of Osseointegration
InjurySep 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20195658 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.