SwishTapered™ Implant 934810Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.8mmD x 10mmL, 4.8mmD Platform · Implant
All models of SwishTapered Implant (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307106463), received between Dec 12, 2018 and Mar 3, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Loss of Osseointegration1
Patient problems
- Failure of Implant2
- Inflammation1
- No Consequences Or Impact To Patient1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 13660172 ↗MalfunctionDec 12, 2018Break; Break
PER COMPLAINT (B)(4), A DENTAL IMPLANT WAS STUCK WHILE SCREWING DURING CLINICAL PROCEDURE. THE DENTIST TRIED TO REMOVE THE IMPLANT BY UNSCREWING IT, BUT HE COULD NOT UNSCREW IT WITH NORMAL INSTRUMENTS. THE IMPLANT WAS REMOVED BY GRASPING WITH FORCEPS. CONSEQUENTLY, THE IMPLANT WAS BROKEN. THE INITIAL PLACEMENT PROCEDURE WAS COMPLETED WITHIN THE SAME DAY. THE PATIENT DID NOT EXPERIENCE ADVERSE CONSEQUENCES.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8157218 ↗
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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