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Multi-unit Abutment 29192 (UDI 07332747003109)Recalls & reported problems

Nobel Biocare AB · 30° Multi-unit Abutment Bmk Syst RP 4 mm · Class 2 · Implant

Adverse event reports
11
Deaths reported
0
Injuries reported
10
Recalls naming it
0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07332747003109), received between Oct 15, 2019 and Feb 12, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 4 reportsMar 2025: 0 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 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate5
  • Loss of Osseointegration4
  • Insufficient Device Problem Information2

Patient problems

  • Failure of Implant11
  • Pain4
  • Numbness2
  • Unspecified Infection2

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 12, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21370104 ↗
  • InjuryFeb 12, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21370069 ↗
  • InjuryFeb 12, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21369602 ↗
  • InjuryFeb 12, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21369601 ↗
  • MalfunctionJan 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    SURFACE DEFECT.

    Patient problems: Failure of Implant

    MAUDE report 21096719 ↗
  • InjuryJan 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    SURFACE DEFECT.

    Patient problems: Failure of Implant

    MAUDE report 21096709 ↗
  • InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16296689 ↗
  • InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16296687 ↗
  • InjuryFeb 2, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant; Numbness; Pain; Unspecified Infection

    MAUDE report 13427488 ↗
  • InjuryFeb 2, 2022Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant; Numbness; Pain; Unspecified Infection

    MAUDE report 13427482 ↗
  • InjuryOct 15, 2019Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 9190798 ↗

Other Abutment, implant, dental, endosseous devices

All Abutment, implant, dental, endosseous devices →

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