Replace Select™ 29414 (UDI 07332747000146)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered TiU RP 4.3x13mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select root-form implant is placed in bone. Most of the 1,372 reports describe the implant losing its bond with the bone, and some mention pain, infection or numbness. The reports include no deaths and 1,370 injuries. Reports fell from 26 in the prior 12 months to 12 in the latest 12 months. 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
- 1,374
- Deaths reported
- 0
- Injuries reported
- 1,372
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,374 adverse event reports that list this exact device (DI 07332747000146), received between Sep 10, 2019 and Sep 16, 2026 — classified as 1,372 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (971 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 Osseointegration971
- Failure to Osseointegrate306
- Osseointegration Problem62
- Adverse Event Without Identified Device or Use Problem16
- Fracture12
- Malposition of Device3
- Device Markings/Labelling Problem2
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant1,336
- Pain283
- Unspecified Infection190
- Numbness72
- No Clinical Signs, Symptoms or Conditions26
- Abscess8
- Bone Fracture(s)2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 1,374 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796252 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796250 ↗InjuryJun 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25671339 ↗InjuryJun 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25671335 ↗InjuryMay 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25130646 ↗InjuryMay 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25130435 ↗InjuryApr 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25029410 ↗InjuryApr 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25023161 ↗InjuryMar 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541610 ↗InjuryMar 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540348 ↗InjuryFeb 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24382680 ↗InjuryFeb 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24382671 ↗InjuryNov 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 12, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22488928 ↗InjuryJul 12, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22488926 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453658 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453636 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453613 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453213 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453139 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453131 ↗InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.