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BioHorizons CBD-50Recalls & reported problems

Biohorizons Implant Systems, Inc · Tapered Crestal Bone Drill, Blue, 5.0mm · Class 1

Adverse event reports
13
Deaths reported
0
Injuries reported
13
Recalls naming it
0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847236017415), received between Feb 15, 2024 and Aug 24, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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: 1 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: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 3 reportsDec 2025: 1 reportsJan 2026: 2 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate13
  • Loss of Osseointegration1

Patient problems

  • Insufficient Information13

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 24, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50411779 ↗
  • InjuryMar 15, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 24601987 ↗
  • InjuryJan 16, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE

    Patient problems: Insufficient Information

    MAUDE report 24095667 ↗
  • InjuryJan 15, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 24079785 ↗
  • InjuryDec 22, 2025Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 23862589 ↗
  • InjuryNov 25, 2025Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 23644754 ↗
  • InjuryNov 24, 2025Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 23632651 ↗
  • InjuryNov 24, 2025Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 23631920 ↗
  • InjuryAug 15, 2025Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 22819256 ↗
  • InjuryJun 13, 2025Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 22207031 ↗
  • InjuryJun 7, 2025Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 22162466 ↗
  • InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 21284127 ↗
  • InjuryFeb 15, 2024Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 18717525 ↗

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