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NobelReplace® 32185Recalls & reported problems

Nobel Biocare AB · NOBELREPLACE® Straight Groovy RP 4x18mm · Class 2 · Implant

Adverse event reports
20
Deaths reported
0
Injuries reported
20
Recalls naming it
0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07332747019124), received between Dec 1, 2022 and Mar 1, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (20 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 2 reportsJul 2024: 2 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 2 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Loss of Osseointegration20

Patient problems

  • Failure of Implant20

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 21500733 ↗
  • InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 21500732 ↗
  • InjuryDec 6, 2024Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 20860074 ↗
  • InjuryDec 5, 2024Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 20859060 ↗
  • InjuryJul 11, 2024Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 19725330 ↗
  • InjuryJul 11, 2024Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 19724937 ↗
  • InjuryJun 18, 2024Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 19562574 ↗
  • InjuryJun 18, 2024Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 19562432 ↗
  • InjuryOct 23, 2023Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 17989768 ↗
  • InjuryOct 23, 2023Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 17989361 ↗
  • InjuryDec 1, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 15900483 ↗
  • InjuryDec 1, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 15899910 ↗
  • InjuryDec 1, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 15899623 ↗
  • InjuryDec 1, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 15898991 ↗
  • InjuryDec 1, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 15898617 ↗
  • InjuryDec 1, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 15898099 ↗
  • InjuryDec 1, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 15897259 ↗
  • InjuryDec 1, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 15896604 ↗
  • InjuryDec 1, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 15896448 ↗
  • InjuryDec 1, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 15896047 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.