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FRIADENT® 32464305Recalls & reported problems

Dentsply Implants Manufacturing GmbH · Screw for EstheticBase · Class 2 · Implant

All models of FRIADENT (23)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This FRIADENT EstheticBase screw is used with a dental implant. The 26 reports mainly describe the screw or implant fracturing, sometimes leaving a fragment; they mention 23 injuries and no deaths. No recalls name this device. Reports rose from 3 in the previous 12 months to 20 in the latest 12 months.

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
25
Deaths reported
0
Injuries reported
20
Recalls naming it
0

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07392532231612), received between Oct 17, 2023 and Sep 29, 2026 — classified as 20 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (24 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 5 reportsJan 2026: 2 reportsFeb 2026: 4 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 4 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture24
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions18
  • Failure of Implant7

Recent adverse event reports

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

  • MalfunctionSep 29, 2026Fracture

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50933789 ↗
  • MalfunctionSep 17, 2026Mechanical Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50809582 ↗
  • InjuryJul 28, 2026Fracture

    It was reported that a patient experienced a fracture of a dental abutment screw.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50059390 ↗
  • InjuryMay 28, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25317541 ↗
  • InjuryMay 15, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25185928 ↗
  • InjuryMay 12, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25153938 ↗
  • InjuryMay 1, 2026Fracture

    CUSTOMER REPORTED A FRACTURE OF SCREW - RESCUE SERVICE (B)(4). (B)(6) 2026 DIANZ470: RESCUE SERVICE WILL BE FOLLOWED UP BY CUSTOMER SERVICE AT CCO. IN CASE OF NO FURTHER CONTACT, IT IS UNDERSTOOD THAT THE DENTIST SUCCESSFULLY REMOVED THE FRAGMENT (IF ANY), AND THE IMPLANT WAS RESTORED. OTHERWISE, THE LIFETIME WARRANTY WOULD BE CLAIMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25057116 ↗
  • InjuryMar 25, 2026Fracture

    IT WAS REPORTED THAT, DURING MANUAL TIGHTENING OF THE CROWN SCREW ON (B)(6) 2026, THE SCREW FRACTURED WITHOUT THE APPLICATION OF SIGNIFICANT FORCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24690028 ↗
  • InjuryFeb 26, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL SCREW IMPLANT FRACTURE AND SUBSEQUENT IMPLANT LOSS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24465934 ↗
  • InjuryFeb 26, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL SCREW IMPLANT FRACTURE AND SUBSEQUENT IMPLANT LOSS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24465933 ↗
  • InjuryFeb 17, 2026Fracture

    THE CUSTOMER REPORTED A BROKEN SCREW IN THE DENTAL IMPLANT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24362265 ↗
  • InjuryFeb 13, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24335098 ↗
  • InjuryJan 21, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24128869 ↗
  • InjuryJan 16, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24095554 ↗
  • InjuryDec 31, 2025Fracture; Fracture

    IT WAS REPORTED THAT A CUSTOMER EXPERIENCED AN ABUTMENT SCREW FRACTURED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23933425 ↗
  • MalfunctionDec 26, 2025Fracture; Fracture

    IT WAS REPORTED THAT A CUSTOMER EXPERIENCED FRACTURING OF THE DENTAL IMPLANT SCREW AND SUBSEQUENT IMPLANT LOSS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23900775 ↗
  • InjuryDec 19, 2025Fracture; Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF ABUTMENT.

    Patient problems: Failure of Implant

    MAUDE report 23857764 ↗
  • MalfunctionDec 18, 2025Fracture; Fracture

    IT WAS REPORTED THAT A CUSTOMER EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND REMOVAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23846135 ↗
  • MalfunctionDec 18, 2025Fracture; Fracture

    IT WAS REPORTED THAT A CUSTOMER EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND REMOVAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23846134 ↗
  • InjuryJun 26, 2025Fracture; Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 22342867 ↗
  • InjuryFeb 11, 2025Fracture; Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 21356795 ↗
  • InjuryNov 4, 2024Fracture; Fracture

    IT WAS REPORTED, THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 20598002 ↗
  • InjuryMay 15, 2024Fracture; Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 19318496 ↗
  • InjuryFeb 19, 2024Fracture; Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 18730365 ↗
  • InjuryOct 17, 2023Fracture; Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Patient problems: Failure of Implant

    MAUDE report 17948867 ↗

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Sources and updates

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