Reflect Implant System RA3511CRecalls & reported problems
Integrated Dental Systems, LLC · Reflect Rapid 3.5 x 11.5mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00817773024030), received between Nov 14, 2022 and Jan 8, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate4
- Patient Device Interaction Problem3
- Fracture2
Patient problems
- Failure of Implant9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 21103722 ↗MalfunctionApr 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19193833 ↗MalfunctionApr 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19065039 ↗MalfunctionNov 17, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE
Patient problems: Failure of Implant
MAUDE report 18159057 ↗MalfunctionOct 19, 2023Fracture; Fracture
MalfunctionOct 19, 2023Fracture; Fracture
MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT (B)(6) RECEIVED IMPLANT (PRODUCT NAME: RFLT RAPID RA3511C REFLECT RAPID FIXTURE Ø3.5MM X 11.5 L) ON (B)(6) 2022) BUT EXPERIENCED MOBILITY 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 15792123 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT (B)(6) RECEIVED IMPLANT (RFLT RAPID RA3511C REFLECT RAPID FIXTURE Ø3.5MM X 11.5 L) ON (B)(6) 2022, EXPERIENCED LOSS OF INTEGRATION ON (B)(6) 2022. X-RAYS WERE PROVIDED BY THE DENTIST. IMPLANT REPLACEMENT WAS SENT TO DR. (B)(6) ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15792083 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT D SAMKO SR. RECEIVED IMPLANT (RFLT RAPID RA3511C REFLECT RAPID FIXTURE Ø3.5MM X 11.5 L) ON (B)(6) 2021 AND EXPERIENCED A FAILURE TO INTEGRATE WHICH LEAD TO THE IMPLANT BEING REMOVED ON (B)(6) 2022. X-RAYS WERE PROVIDED BY THE DENTIS.. AN IMPLANT REPLACEMENT WAS SENT TO KOUSSA DENTAL ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15790514 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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