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Reflect RA3585CRecalls & reported problems

Integrated Dental Systems, LLC · Reflect Rapid Fixture Ø3.5mm X 8.5L · Class 2 · Implant

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

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00817773024016), received between Nov 14, 2022 and Jul 10, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 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.

Most reported problems

Device problems

  • Patient Device Interaction Problem6
  • Failure to Osseointegrate1

Patient problems

  • Failure of Implant7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 10, 2023Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 17294275 ↗
  • MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    PATIENT B PHILLIPS RECEIVED IMPLANT (RFLT RAPID RA3585C REFLECT RAPID FIXTURE Ø3.5MM X 8.5L) ON (B)(6) 2022 AND EXPERIENCED FAILURE TO INTEGRATE WHICH LEAD TO THE BEING IMPLANT REMOVED ON (B)(6) 2022. X-RAYS WERE PROVIDED WER PROVIDED BY THE DENTIS. IMPLANT REPLACEMENT WAS SENT TO DT. ANDREW GLENN ON (B)(6) 2022..

    Patient problems: Failure of Implant

    MAUDE report 15792866 ↗
  • MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    PATIENT B PHILLIPS RECEIVED IMPLANT (RFLT RAPID RA3585C REFLECT RAPID FIXTURE Ø3.5MM X 8.5L) ON (B)(6) 2022, EXPERIENCED FAILURE TO INTEGRATE AND HAD THE IMPLANT REMOVED ON (B)(6) 2022. X-RAYS WERE PROVIDED BY THE DENTIST. IMPLANT REPLACEMENT WAS SENT TO DT. ANDREW GLENN ON (B)(6) 2022.

    Patient problems: Failure of Implant

    MAUDE report 15792556 ↗
  • MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    PATIENT (B)(6) HAD IMPLANT (RFLT RAPID RA3585C REFLECT RAPID FIXTURE Ø3.5MM X 8.5L) ON (B)(6) 2022 BUT EXPERIENCE A LOSS OF INTEGRATION AND HAD THE IMPLANT REMOVED ON (B)(6) 2022. A REPLACEMENT IMPLANT WAS SENT TO DR. (B)(6).

    Patient problems: Failure of Implant

    MAUDE report 15792416 ↗
  • MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    DPATIENT B PHILLIPS RECEIVED IMPLANT (RFLT RAPID RA3585C REFLECT RAPID FIXTURE Ø3.5MM X 8.5L) ON (B)(6) 2022 AND EXPERIENCED FAILURE TO INTEGRATE WHICH LEAD TO THE IMPLANT BEING REMOVED ON (B)(6) 2022. X-RAYS WERE PROVIDED BY THE DENTIST. IMPLANT REPLACEMENT WAS SENT TO DR. ANDREW GLENN ON (B)(6) 2022.

    Patient problems: Failure of Implant

    MAUDE report 15792350 ↗
  • MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    PATIENT (B)(6) RECEIVED IMPLANT (RFLT RAPID RA3585C REFLECT RAPID FIXTURE Ø3.5MM X 8.5L) ON (B)(6) 2021 AND EXPERIENCED LOSS OF INTEGRATION WHICH LED TO THE IMPLANT BEING REMOVED ON (B)(6) 2022. X-RAYS WERE PROVIDED BY THE DENTIST. IMPLANT REPLACEMENT WAS SENT TO DR. (B)(6) ON 06/27/2022.

    Patient problems: Failure of Implant

    MAUDE report 15792155 ↗
  • MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    PATIENT K NEMETH RECEIVED IMPLANT (RFLT RAPID RA3585C REFLECT RAPID FIXTURE Ø3.5MM X 8.5L) ON (B)(6) 2021 AND EXPERIENCED FAILURE TO INTEGRATE WHICH LED TO HAVING THE IMPLANT REMOVED ON (B)(6) 2021. X-RAYS WERE PROVIDED BY THE DENTIST. IMPLANT REPLACEMENT WAS SENT TO GRANT DENTAL-MERIDIAN ON (B)(6) 2022.

    Patient problems: Failure of Implant

    MAUDE report 15790627 ↗

Other Implant, Endosseous, Root-Form devices

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Sources and updates

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