Replace Select™ 37302 (UDI 07332747073478)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC NP 3.5x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant is placed into bone. Its 256 reports mostly describe the implant failing to bond with the bone, with some reporting fractured components. There were no deaths and 253 injuries, and reports fell to 2 in the last 12 months from 16 in the 12 months before. 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
- 260
- Deaths reported
- 0
- Injuries reported
- 257
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 07332747073478), received between Sep 11, 2019 and Sep 14, 2026 — classified as 257 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (120 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 Osseointegrate120
- Loss of Osseointegration95
- Osseointegration Problem22
- Fracture15
- Adverse Event Without Identified Device or Use Problem5
- Patient Device Interaction Problem3
- Device Damaged by Another Device1
Patient problems
- Failure of Implant242
- Pain45
- Unspecified Infection23
- No Clinical Signs, Symptoms or Conditions15
- Numbness7
- Bone Fracture(s)1
- Inflammation1
- Sinus Perforation1
Recent adverse event reports
The 25 most recent of 260 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Loss of Osseointegration
InjurySep 14, 2026Loss of Osseointegration
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743844 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743842 ↗InjuryJan 23, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24169647 ↗InjuryJan 23, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24169643 ↗InjurySep 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23033463 ↗InjurySep 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23033460 ↗InjuryAug 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22764766 ↗InjuryAug 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22764742 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22607195 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22607100 ↗InjuryJul 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22486557 ↗InjuryJul 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22486544 ↗InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 3, 2025Fracture; Fracture
InjuryJan 3, 2025Fracture; Fracture
InjuryAug 27, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20079519 ↗InjuryAug 27, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20079297 ↗InjuryMay 23, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19387429 ↗
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
- 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.