SwishPlus® Implant 925708Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · 5.7mmD x 8mmL, 6.5mmD Platform · Implant
All models of SwishPlus Implant (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307106296), received between Nov 2, 2018 and Dec 27, 2019 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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
- Failure to Osseointegrate2
- Labelling, Instructions for Use or Training Problem1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant3
- No Consequences Or Impact To Patient2
- Impaired Healing1
- Inflammation1
- No Information1
- No Known Impact Or Consequence To Patient1
- Osteopenia/ Osteoporosis1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 27, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; No Information
MAUDE report 9522922 ↗InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OR LOSS OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Impaired Healing; Inflammation; No Consequences Or Impact To Patient; Unspecified Infection
MAUDE report 8979844 ↗InjuryMar 19, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
PER COMPLAINT (B)(4), DURING IMPLANT PLACEMENT ON TOOTH #19, THE IMPLANT FENESTRATED THE PATIENT'S LINGUAL PLATE. THE PATIENT EXPERIENCED PAIN AND NO OTHER IMPACT. THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient; Osteopenia/ Osteoporosis; Pain
MAUDE report 8434018 ↗MalfunctionNov 2, 2018Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
PER COMPLAINT (B)(4), THE CUSTOMER RECEIVED VIALS WITH INCORRECT LABEL AND CAP COLORING.NO ADVERSE PATIENT IMPACT WAS REPORTED AS A RESULT OF THIS COMPLAINT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8035571 ↗
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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