SwishTapered™ Implant 934806Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · 4.8mmD x 6mmL, 4.8mmD Platform · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 19
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10841307106449), received between Dec 18, 2017 and Apr 26, 2019 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (18 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 /Shipping18
Detachment of Device or Device Component1

Patient problems

Not Applicable18
Failure of Implant1

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
PER COMPLAINT (B)(4), DURING THE CLINICAL PROCEDURE, IMPLANTS COULD NOT ACHIEVE PRIMARY STABILITY. THEY WERE REPLACED WITH A WIDER IMPLANT, BUT THE IMPLANT USED BECAME STUCK WITHIN THE PLACEMENT INSTRUMENT. THE IMPLANT WAS EXTRACTED AS A RESULT.
Patient problems: Failure of Implant
MAUDE report 8553640 ↗
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 7125837 ↗
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 7125835 ↗
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 7125832 ↗
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 7125818 ↗
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 7125814 ↗
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 7125786 ↗
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 7125780 ↗
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 7125777 ↗
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 7125775 ↗
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 7125744 ↗
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 7125738 ↗
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 7125736 ↗
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 7125732 ↗
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 7125716 ↗
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 7125711 ↗
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 7125709 ↗
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 7125704 ↗
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 7125679 ↗

Device details

UDI-DI	`10841307106449`
Brand	SwishTapered™ Implant
Model	934806
Company	Implant Direct Sybron Manufacturing LLC
Product code	—
Class	—
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Sep 4, 2019

Device type (GMDN): Dental implant system

A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

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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