Reflect Implant System RA5010CRecalls & reported problems
Integrated Dental Systems, LLC · Reflect Rapid 5.0 x 10mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00817773024122), received between Nov 14, 2022 and Aug 13, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate6
- Patient Device Interaction Problem3
- Fracture1
- Loss of Osseointegration1
Patient problems
- Failure of Implant11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Loss of Osseointegration
Patient problems: Failure of Implant
MAUDE report 50240554 ↗MalfunctionJul 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19819551 ↗MalfunctionJul 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19819542 ↗MalfunctionFeb 16, 2024Fracture; Fracture
MalfunctionOct 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17967272 ↗MalfunctionSep 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17837495 ↗MalfunctionAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17558537 ↗MalfunctionAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17558532 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
TIENT J KULAK RECEIVED IMPLANT (RFLT RAPID RA5010C REFLECT RAPID FIXTURE Ø5.0MM X 10 L) (B)(6) 2022. THE PATIENT EXPERIENCED A FAILURE TO INTEGRATE AND HAD THE IMPLANT REMOVED ON (B)(6) 2022, X-RAYS WERE PROVIDED. A REPLECEMENT IMPLANT WAS SENT TO AVON CENTER DENTISTRY ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15792051 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT (B)(6) RECEIVED IMPLANT (RFLT RAPID RA5010C REFLECT RAPID FIXTURE Ø5.0MM X 10 L) ON (B)(6) 2021, EXPERIENCED BONE LOSS WHICH LED TO A LOSS OF INTEGRATION. THIS LED TO THE IMPLANT BEING REMOVED ON (B)(4) 2022. X-RAYS WERE NOT PROVIDED BY THE DENTIS. IMPLANT REPLACEMENT WAS SENT TO DR. (B)(6) ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15791627 ↗MalfunctionNov 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT S TROMBINO RECEIVED IMPLANT (RFLT RAPID RA5010C REFLECT RAPID FIXTURE Ø5.0MM X 10 L) ON (B)(6) 2021, EXPERIENCED BONE LOSS WHICH LEAD TO A FAILURE TO INTEGRATE AND THE IMPLANT WAS REMOVED ON (B)(6) 2022. X-RAYS WERE PROVIDED BY THE DENTIST. IMPLANT REPLACEMENT WAS SENT TO (B)(6) ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 15791062 ↗
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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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