Replace Select™ 37318 (UDI 07332747160987)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC 6.0 6.0x13mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant is a tapered screw-shaped implant used as a tooth root replacement in the jaw. The 44 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that fusion after it had formed, sometimes with pain or infection; 42 reports involved injuries and no deaths were reported. There are no recalls naming this device, and no reports were filed in the past 12 months, down from 8 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
- 44
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07332747160987), received between May 25, 2022 and Aug 2, 2025 — classified as 42 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (28 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 Osseointegrate28
- Loss of Osseointegration10
- Adverse Event Without Identified Device or Use Problem2
- Device Markings/Labelling Problem2
- Osseointegration Problem2
Patient problems
- Failure of Implant38
- No Clinical Signs, Symptoms or Conditions6
- Osteomyelitis2
- Pain2
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22695311 ↗InjuryAug 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22695307 ↗InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22354097 ↗InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22354063 ↗InjuryFeb 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 20, 2024Osseointegration Problem; Osseointegration Problem
InjuryNov 20, 2024Osseointegration Problem; Osseointegration Problem
InjurySep 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE
Patient problems: Failure of Implant
MAUDE report 20286690 ↗InjurySep 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE
Patient problems: Failure of Implant
MAUDE report 20285540 ↗InjuryJun 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19638341 ↗InjuryJun 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19637982 ↗InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19523857 ↗InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19523837 ↗InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19523680 ↗InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19523679 ↗InjuryApr 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
THE IMPLANT MALFUNCTIONED DUE TO WRONG PART USED. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19166940 ↗MalfunctionApr 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
THE IMPLANT MALFUNCTIONED DUE TO WRONG PART USED. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19166939 ↗InjuryMar 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19008076 ↗InjuryMar 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19008035 ↗InjuryDec 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18359481 ↗InjuryDec 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18359434 ↗InjuryNov 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18174883 ↗InjuryNov 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18174805 ↗InjuryOct 16, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17943563 ↗
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.