SwishTapered™ Implant 934106Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · 4.1mmD x 6mmL, 4.8mmD Platform · Implant

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

Adverse event reports: 12
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10841307106388), received between Dec 18, 2017 and Sep 29, 2021 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (8 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 /Shipping8
Loss of Osseointegration2
Failure to Osseointegrate1
Osseointegration Problem1

Patient problems

Not Applicable8
Failure of Implant4
Osteopenia/ Osteoporosis2
Impaired Healing1
Inflammation1
Pain1

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

InjurySep 29, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 12547738 ↗
InjurySep 29, 2021Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 12547734 ↗
InjurySep 21, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12503664 ↗
InjuryMay 12, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Impaired Healing; Inflammation; Pain
MAUDE report 11815612 ↗
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 7125802 ↗
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 7125794 ↗
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 7125770 ↗
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 7125769 ↗
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 7125759 ↗
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 7125754 ↗
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 7125707 ↗
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 7125676 ↗

Device details

UDI-DI	`10841307106388`
Brand	SwishTapered™ Implant
Model	934106
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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