Replace Select™ 37309 (UDI 07332747160895)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC RP 4.3x16mm · Class 2 · Implant
Quick summary
This is a Nobel Biocare Replace Select Tapered implant. Most of the 84 reports describe the implant failing to bond with the bone, and some describe the device moving from its intended position, parts separating and numbness. There are 82 injuries and no deaths among the reports. No recalls name this device. Reports rose in the last 12 months, with 8 compared with 2 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
- 84
- Deaths reported
- 0
- Injuries reported
- 82
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 07332747160895), received between Dec 1, 2021 and Mar 21, 2026 — classified as 82 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (56 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 Osseointegrate56
- Loss of Osseointegration16
- Fracture4
- Adverse Event Without Identified Device or Use Problem2
- Migration2
- Osseointegration Problem2
- Separation Failure2
Patient problems
- Failure of Implant72
- Pain20
- Numbness10
- No Clinical Signs, Symptoms or Conditions6
- Unspecified Infection6
- Bone Fracture(s)2
Recent adverse event reports
The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.
InjuryMar 21, 2026Loss of Osseointegration
InjuryMar 21, 2026Loss of Osseointegration
InjuryFeb 26, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24462902 ↗InjuryFeb 26, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24462899 ↗InjuryJan 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23983816 ↗InjuryJan 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23983805 ↗InjuryJan 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23983777 ↗InjuryJan 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23983776 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20572818 ↗InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20572686 ↗InjurySep 20, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20272506 ↗InjurySep 20, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20271294 ↗InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19365402 ↗InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19365358 ↗InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION. 21.05.2024 15:31:53 CET (5023852). USER:5023852 RECEIVED DATE OF THE RETURN PRODUCT:21/05/2024.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19365327 ↗InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19365324 ↗InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION. (B)(6) 2024 15:31:53 CET (5023852). USER:5023852 RECEIVED DATE OF THE RETURN PRODUCT:21/05/2024.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19365250 ↗InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 19365229 ↗MalfunctionMay 17, 2024Fracture; Fracture
InjuryMay 17, 2024Fracture; Fracture
InjuryApr 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19216609 ↗InjuryApr 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19216528 ↗InjuryMar 12, 2024Fracture; Fracture
THE IMPLANT MALFUNCTIONED DUE TO PART FRACTURED. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 18889467 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.