SwishTapered™ Implant 934812Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.8mmD 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
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10841307106470), received between Dec 18, 2017 and Mar 14, 2019 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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 18, 2026.
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping6
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
Patient problems
- Not Applicable6
- Failure of Implant1
- Nerve Damage1
- Numbness1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2019Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
PER COMPLAINT (B)(4), A PATIENT LOST FEELING IN JAW SINCE THEIR DENTAL IMPLANT WAS PLACED. THE PATIENT EXPERIENCED NUMBNESS AND TARTAR. A STEROID PACK AND ANTIBIOTICS WERE USED TO GAIN BACK THE FEELING, BUT WAS UNSUCCESSFUL. THE IMPLANT WAS EXPLANTED.
Patient problems: Failure of Implant; Nerve Damage; Numbness
MAUDE report 8421889 ↗MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125810 ↗MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED..
Patient problems: Not Applicable
MAUDE report 7125778 ↗MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY.
Patient problems: Not Applicable
MAUDE report 7125751 ↗MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125741 ↗MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125733 ↗MalfunctionDec 18, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
NO ADVERSE EVENT REPORTED. THE IMPLANT EXTENDER IS PACKAGED UPSIDE DOWN. THIS MAY RESULT IN THE EXTENDER BEING PLACED ON THE IMPLANT INCORRECTLY IF THE EXTENDER IS USED.
Patient problems: Not Applicable
MAUDE report 7125705 ↗
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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