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BioHorizons CTR3810Recalls & reported problems

Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.8 x 10.5mm, RBT · Class 2 · Implant

Quick summary

This BioHorizons Tapered Pro Conical implant has 87 reports in the FDA database, all coded as injuries and none as deaths. Most reports describe the implant failing to integrate with the bone, and some describe it being removed soon after placement. Reports rose to 74 in the past 12 months from 13 the year before. 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
90
Deaths reported
0
Injuries reported
90
Recalls naming it
0

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00847236024314), received between Nov 18, 2024 and Sep 30, 2026 — classified as 90 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (83 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: 1 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 3 reportsAug 2025: 1 reportsSep 2025: 2 reportsOct 2025: 1 reportsNov 2025: 4 reportsDec 2025: 5 reportsJan 2026: 5 reportsFeb 2026: 6 reportsMar 2026: 11 reportsApr 2026: 11 reportsMay 2026: 4 reportsJun 2026: 9 reportsJul 2026: 12 reportsAug 2026: 6 reportsSep 2026: 4 reportsOct 2026: 0 reports20242025202612
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate83
  • Use of Device Problem12

Patient problems

  • Insufficient Information90

Recent adverse event reports

The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50949855 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: Insufficient Information

    MAUDE report 50914268 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50914115 ↗
  • InjurySep 21, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50837324 ↗
  • InjuryAug 25, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50430472 ↗
  • InjuryAug 16, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50268402 ↗
  • InjuryAug 16, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50268354 ↗
  • InjuryAug 12, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50227102 ↗
  • InjuryAug 5, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50140004 ↗
  • InjuryAug 5, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50139945 ↗
  • InjuryJul 21, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 25889496 ↗
  • InjuryJul 10, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE

    Patient problems: Insufficient Information

    MAUDE report 25781515 ↗
  • InjuryJul 9, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25773735 ↗
  • InjuryJul 9, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25773723 ↗
  • InjuryJul 9, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25773716 ↗
  • InjuryJul 9, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25773706 ↗
  • InjuryJul 9, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25773696 ↗
  • InjuryJul 9, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25773694 ↗
  • InjuryJul 9, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25764752 ↗
  • InjuryJul 7, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25735191 ↗
  • InjuryJul 7, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25735181 ↗
  • InjuryJul 7, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25735079 ↗
  • InjuryJun 25, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25620681 ↗
  • InjuryJun 24, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25606462 ↗
  • InjuryJun 23, 2026Use of Device Problem

    IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.

    Patient problems: Insufficient Information

    MAUDE report 25595510 ↗

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.