SwishTapered™ Implant 934112Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.1mmD x 12mmL, 4.8mmD Platform · Implant
All models of SwishTapered Implant (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307106418), received between Feb 28, 2019 and May 24, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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
- Loss of Osseointegration2
- Device Appears to Trigger Rejection1
Patient problems
- Failure of Implant3
- Inflammation2
- Nerve Damage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 14489103 ↗InjuryNov 15, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 12810868 ↗InjuryFeb 28, 2019Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PER COMPLAINT (B)(4), A PATIENT PRESENTED TO THE DENTIST. THEIR DENTAL IMPLANT HAD TO BE REMOVED BECAUSE THE PATIENT SAID THAT THE SIDE THE IMPLANT WAS ON WENT NUMB.
Patient problems: Failure of Implant; Nerve Damage
MAUDE report 8380303 ↗
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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