Replace Select™ 37308 (UDI 07332747073416)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC RP 4.3x13mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Replace Select implant, placed into the bone, has 340 reports, 339 of them injuries and no deaths. The reports mostly describe failure to bond with the surrounding bone or losing that bond later, with some patients reporting pain or infection. Reports in the last 12 months number 4, down from 12 in the previous 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
- 340
- Deaths reported
- 0
- Injuries reported
- 339
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 340 adverse event reports that list this exact device (DI 07332747073416), received between Sep 10, 2019 and Jan 29, 2026 — classified as 339 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (150 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 Osseointegration150
- Failure to Osseointegrate147
- Osseointegration Problem22
- Fracture15
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant330
- Pain48
- Unspecified Infection20
- Numbness12
- No Clinical Signs, Symptoms or Conditions8
- Inflammation4
- Abscess2
Recent adverse event reports
The 25 most recent of 340 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24216521 ↗InjuryJan 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24216514 ↗InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23444084 ↗InjuryOct 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23444074 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23296790 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23296275 ↗InjuryJul 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22626619 ↗InjuryJul 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22626371 ↗InjuryFeb 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21308486 ↗InjuryFeb 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21308469 ↗InjuryJan 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 27, 2024Fracture; Fracture
COMPONENT FRACTURED
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20802014 ↗InjuryNov 27, 2024Fracture; Fracture
COMPONENT FRACTURED
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20801942 ↗InjuryOct 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20446118 ↗InjuryOct 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20445345 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20327548 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20324670 ↗InjuryJul 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19705347 ↗InjuryJul 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19704478 ↗InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19523066 ↗InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19523041 ↗InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19523002 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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