Replace Select™ 37316 (UDI 07332747073331)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC 6.0 6.0x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant is a root-form screw placed into the jaw to replace a missing tooth. The 45 reports mostly describe the implant not fusing properly with the surrounding bone, so it fails and has to be removed, along with pain, infection, and abscess. All 45 involve injuries and no deaths are reported. No recalls name this device, and no reports were filed in the past 12 months compared with 2 in the prior12 months.
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
- 45
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 07332747073331), received between Sep 11, 2019 and Feb 22, 2025 — classified as 45 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (25 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 Osseointegrate25
- Loss of Osseointegration14
- Insufficient Device Problem Information4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Failure of Implant41
- Pain9
- Insufficient Information4
- Unspecified Infection4
- Abscess2
- Osteomyelitis2
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 22, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20044653 ↗InjuryAug 22, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20042779 ↗InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 22, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16594286 ↗InjuryMar 22, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 16594285 ↗InjuryOct 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IMPLANT FAILED DUE TO UNCONFIRMED ISSUE.
Patient problems: Insufficient Information
MAUDE report 15567256 ↗InjuryOct 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IMPLANT FAILED DUE TO UNCONFIRMED ISSUE.
Patient problems: Insufficient Information
MAUDE report 15565415 ↗InjuryJun 13, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 14680248 ↗InjuryJun 13, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 14680049 ↗InjuryJun 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 14635556 ↗InjuryJun 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 14635459 ↗InjuryMay 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER INDICATED THE IMPLANT FAILED, HOWEVER BASED ON THE AVAILABLE INFORMATION THE EXACT ISSUE COULD NOT BE IDENTIFIED.
Patient problems: Insufficient Information; Pain
MAUDE report 14401487 ↗InjuryMay 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER INDICATED THE IMPLANT FAILED, HOWEVER BASED ON THE AVAILABLE INFORMATION THE EXACT ISSUE COULD NOT BE IDENTIFIED.
Patient problems: Insufficient Information; Pain
MAUDE report 14401426 ↗InjuryMar 2, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 13655877 ↗InjuryMar 2, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 13655861 ↗InjuryNov 8, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 12774951 ↗InjuryNov 8, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 12774918 ↗InjuryMar 29, 2020Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 9895639 ↗InjuryMar 29, 2020Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 9895568 ↗InjuryMar 28, 2020Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 9894186 ↗InjuryFeb 21, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9736758 ↗InjuryFeb 21, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 9736750 ↗
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.