Replace Select™ 37307 (UDI 07332747160871)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC RP 4.3x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant has 525 adverse event reports, with no deaths and 516 injuries. Most describe implants that failed to fuse with the jawbone, and some reports mention infection and pain. 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
- 532
- Deaths reported
- 0
- Injuries reported
- 523
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 532 adverse event reports that list this exact device (DI 07332747160871), received between Nov 4, 2021 and Sep 30, 2026 — classified as 523 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (308 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 Osseointegrate308
- Loss of Osseointegration151
- Osseointegration Problem34
- Fracture11
- Migration9
- Adverse Event Without Identified Device or Use Problem8
- Patient Device Interaction Problem4
- Activation, Positioning or Separation Problem2
Patient problems
- Failure of Implant330
- No Clinical Signs, Symptoms or Conditions111
- Unspecified Infection78
- Pain39
- Inflammation16
- Numbness16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
- Abscess7
Recent adverse event reports
The 25 most recent of 532 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953681 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953679 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940735 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940733 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940730 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940729 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50796039 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50796033 ↗InjurySep 14, 2026Failure to Osseointegrate
InjurySep 14, 2026Failure to Osseointegrate
InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486977 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486974 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358683 ↗InjuryAug 4, 2026Loss of Osseointegration
InjuryAug 4, 2026Loss of Osseointegration
InjuryAug 4, 2026Loss of Osseointegration
InjuryAug 4, 2026Loss of Osseointegration
InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046689 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046685 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25755619 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25755611 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 25741343 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 25741341 ↗InjuryJul 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25709146 ↗InjuryJul 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25709020 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.