SwishPlus® Implant 924810WRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.8mmD x 10mmL, 6.5mmD Platform · Implant
All models of SwishPlus Implant (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This SwishPlus dental implant is a small screw-shaped fixture used to anchor a replacement tooth in the jawbone. The 31 reports mostly describe implants that did not fuse properly with the surrounding bone after placement, so they loosened or had to be removed, along with units that arrived from the manufacturer disassembled or damaged. Reports mention 15 injuries and no deaths; patients cited pain and inflammation. No recalls name this device, and reports have not appeared in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10841307106258), received between Dec 18, 2017 and Sep 27, 2023 — classified as 15 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (16 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 /Shipping16
- Failure to Osseointegrate8
- Loss of Osseointegration4
- Patient Device Interaction Problem1
- Positioning Failure1
- Positioning Problem1
- Use of Device Problem1
Patient problems
- Not Applicable16
- Failure of Implant15
- No Consequences Or Impact To Patient5
- Pain5
- Inflammation2
- Osteopenia/ Osteoporosis2
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2023Loss 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 17825215 ↗InjuryMay 5, 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; Pain
MAUDE report 14286895 ↗InjuryApr 29, 2022Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis; Pain
MAUDE report 14250076 ↗InjuryApr 11, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant
MAUDE report 14074530 ↗InjuryApr 19, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), DURING CLINICAL PROCEDURE, THERE WAS AN ERROR IN SURGICAL PROTOCOL.
Patient problems: Failure of Implant
MAUDE report 11685239 ↗InjuryJan 29, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 11250569 ↗InjuryMar 27, 2020Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9887510 ↗InjuryFeb 27, 2020Failure 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; No Consequences Or Impact To Patient
MAUDE report 9762258 ↗InjuryJan 22, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), DURING LABORATORY PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9614975 ↗InjuryDec 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9464637 ↗InjuryDec 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Pain
MAUDE report 9464616 ↗InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK IT WAS OBSERVED THAT PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 8989848 ↗InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK IT WAS OBSERVED THAT PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Information
MAUDE report 8989844 ↗InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE DUE TO INFECTION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 8987093 ↗InjuryNov 29, 2018Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem
PER COMPLAINT (B)(4), DURING IMPLANT PLACEMENT, THE IMPLANT FENESTRATED THE PATIENT LINGUAL PLATE. THE IMPLANT WAS EXTRACTED.
Patient problems: Failure of Implant; Pain
MAUDE report 8116812 ↗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 7125808 ↗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 7125805 ↗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 7125804 ↗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 7125800 ↗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 7125797 ↗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 7125796 ↗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 7125771 ↗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 7125766 ↗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 7125765 ↗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 7125761 ↗
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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