SwishTapered™ Implant 934808Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.8mmD x 8mmL, 4.8mmD Platform · Implant
All models of SwishTapered Implant (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10841307106456), received between Oct 25, 2019 and May 19, 2022 — classified as 7 injuries.
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.
Most reported problems
Device problems
- Failure to Osseointegrate4
- Loss of Osseointegration2
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant7
- Inflammation5
- Pain5
- Osteopenia/ Osteoporosis3
- Unspecified Infection2
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Hemorrhage/Blood Loss/Bleeding; Inflammation; Osteopenia/ Osteoporosis; Pain
MAUDE report 14435607 ↗InjuryFeb 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain
MAUDE report 11332141 ↗InjuryDec 11, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 10989963 ↗InjuryNov 25, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Pain
MAUDE report 10904220 ↗InjuryNov 25, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Pain
MAUDE report 10904015 ↗InjuryJul 13, 2020Loss of Osseointegration; Loss of Osseointegration
AS PER (B)(4) AFTER A DENTAL IMPLANT DISPLAYED A LOSS OF OSSEOINTEGRATION AND THE IMPLANT WAS EXPLANTED.
Patient problems: Failure of Implant; Inflammation; Pain; Unspecified Infection
MAUDE report 10267777 ↗InjuryOct 25, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
PER COMPLAINT (B)(4), A PATIENT EXPERIENCED PAIN AND BONE LOSS DUE TO IMPLANT STABILITY LOSS. THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 9236785 ↗
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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