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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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