Replace Select™ 37312 (UDI 07332747073379)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC WP 5.0x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant, a screw placed in the jawbone to hold a replacement tooth, has 115 adverse event reports on file. Most describe the implant losing or failing to fuse with the jawbone, and some describe infection or pain. The reports include no deaths and 113 injuries, and 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
- 115
- Deaths reported
- 0
- Injuries reported
- 113
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 07332747073379), received between Sep 11, 2019 and Apr 23, 2026 — classified as 113 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (66 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 Osseointegration66
- Failure to Osseointegrate36
- Osseointegration Problem6
- Adverse Event Without Identified Device or Use Problem3
- Fracture2
- Device Damaged by Another Device1
- Premature Separation1
Patient problems
- Failure of Implant109
- Unspecified Infection25
- Pain19
- No Clinical Signs, Symptoms or Conditions2
- Abscess1
- Numbness1
- Sinus Perforation1
Recent adverse event reports
The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972812 ↗InjuryApr 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972631 ↗InjuryApr 17, 2026Loss of Osseointegration
InjuryApr 17, 2026Loss of Osseointegration
InjuryApr 3, 2026Loss of Osseointegration
InjuryApr 1, 2026Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 6, 2024Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY OF PROSTHETIC RESTORATION.
Patient problems: Failure of Implant
MAUDE report 20623625 ↗InjuryAug 26, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20071279 ↗InjuryAug 26, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20070354 ↗InjuryJul 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19778373 ↗InjuryJul 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19778233 ↗MalfunctionJun 7, 2024Premature Separation; Premature Separation
THE IMPLANT MALFUNCTIONED DUE TO DROPPING FROM THE IMPLANT DRIVER. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 19489233 ↗InjuryMay 16, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19335451 ↗InjuryMay 16, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19335378 ↗InjuryMay 13, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19304409 ↗InjuryMay 13, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19304372 ↗InjuryApr 2, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19029370 ↗
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.