SwishTapered™ Implant 934814Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · 4.8mmD x 14mmL, 4.8mmD Platform · Implant

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

Adverse event reports: 23
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10841307106487), received between Dec 18, 2017 and May 24, 2022 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (22 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 /Shipping22
Loss of Osseointegration1

Patient problems

Not Applicable22
Failure of Implant1
Osteopenia/ Osteoporosis1

Recent adverse event reports

The 23 most recent of 23 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; Osteopenia/ Osteoporosis
MAUDE report 14489047 ↗
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 7125830 ↗
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 7125829 ↗
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 7125828 ↗
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 7125813 ↗
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 7125807 ↗
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 7125806 ↗
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 7125801 ↗
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 7125789 ↗
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 7125785 ↗
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 7125783 ↗
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 7125779 ↗
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 7125774 ↗
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 7125772 ↗
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 7125764 ↗
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 7125755 ↗
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 7125752 ↗
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 7125745 ↗
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 7125730 ↗
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 7125725 ↗
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 7125717 ↗
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 7125713 ↗
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 7125685 ↗

Device details

UDI-DI	`10841307106487`
Brand	SwishTapered™ Implant
Model	934814
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.

How reports and recalls are matched · Editorial policy · Report an error on this page