SwishTapered™ Implant 933310Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 3.3mmD x 10mmL, 3.7mmD Platform · Implant
All models of SwishTapered Implant (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307106340), received between Dec 3, 2018 and Dec 30, 2020 — classified as 4 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
Patient problems
- Failure of Implant4
- Inflammation2
- Pain2
- Aspiration/Inhalation1
- Impaired Healing1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 30, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 11094630 ↗InjuryJul 1, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), IMPLANT DID NOT HAVE PRIMARY STABILITY. THERE WAS NO PATIENT IMPACT.
Patient problems: Failure of Implant; Inflammation; Pain
MAUDE report 10218245 ↗InjuryJul 1, 2020Failure to Osseointegrate; Failure to Osseointegrate
AS PER COMPLAINT (B)(4) DURING A CLINICAL PROCEDURE A DENTAL IMPLANT DISPLAYED A FAILURE OF OSSEOINTEGRATION AND THE IMPLANT WAS EXPLANTED.
Patient problems: Failure of Implant; Inflammation; Pain
MAUDE report 10218141 ↗InjuryDec 3, 2018Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), A PATIENT'S DENTAL IMPLANT FAILED TO INTEGRATE. THE PATIENT SWALLOWED AND EGESTED THE IMPLANT, BUT DID NOT EXPERIENCE ANY SERIOUS EFFECTS AS A RESULT.
Patient problems: Aspiration/Inhalation; Failure of Implant
MAUDE report 8127301 ↗
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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