Replace Select™ 37311 (UDI 07332747073386)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC WP 5.0x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select is a screw-shaped dental implant placed into bone during dental surgery. Most of the 312 reports describe the implant losing its bond with the bone or never bonding, and some mention pain or numbness. There were 311 injury reports and no deaths, and no recalls name this device. Reports rose to 20 in the latest 12 months from 8 in the 12 months before.
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
- 311
- Deaths reported
- 0
- Injuries reported
- 310
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 311 adverse event reports that list this exact device (DI 07332747073386), received between Sep 10, 2019 and Aug 14, 2026 — classified as 310 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (156 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 Osseointegration156
- Failure to Osseointegrate108
- Osseointegration Problem42
- Adverse Event Without Identified Device or Use Problem3
- Fracture2
- Device Damaged by Another Device1
Patient problems
- Failure of Implant290
- Pain80
- Unspecified Infection16
- No Clinical Signs, Symptoms or Conditions8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Numbness5
Recent adverse event reports
The 25 most recent of 311 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263150 ↗InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263146 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50229183 ↗InjuryJul 6, 2026Loss of Osseointegration
InjuryJul 6, 2026Loss of Osseointegration
InjuryJun 25, 2026Loss of Osseointegration
InjuryJun 25, 2026Loss of Osseointegration
InjuryMay 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25193409 ↗InjuryMay 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25192655 ↗InjuryFeb 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24264117 ↗InjuryFeb 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24264096 ↗InjuryFeb 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24263736 ↗InjuryFeb 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24263725 ↗InjuryJan 15, 2026Loss of Osseointegration
InjuryJan 15, 2026Loss of Osseointegration
InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833845 ↗InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833721 ↗InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22427766 ↗InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22427762 ↗InjuryMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
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.