SwishPlus® Implant 924812WRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · 4.8mmD x 12mmL, 6.5mmD Platform · Implant
All models of SwishPlus Implant (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841307106265), received between Sep 11, 2019 and Dec 14, 2022 — classified as 6 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 Osseointegrate5
- Loss of Osseointegration1
Patient problems
- Failure of Implant6
- Inflammation2
- Osteopenia/ Osteoporosis2
- Pain2
- Discomfort1
- No Consequences Or Impact To Patient1
- Swelling1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 14, 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 15976335 ↗InjuryJun 3, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), CLAIM FORM RECEIVED WITH MISSING INFORMATION, CONTACTED CUSTOMER FOR ADDITIONAL INFORMATION.
Patient problems: Discomfort; Failure of Implant; Pain
MAUDE report 11927367 ↗InjuryNov 20, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 10874483 ↗InjuryNov 12, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 10828231 ↗InjuryDec 30, 2019Failure to Osseointegrate; Failure to Osseointegrate
AS PER COMPLAINT (B)(4), DURING A CLINICAL PROCEDURE A DENTAL IMPLANT DISPLAYED A FAILURE OF OSSEOINTEGRATION AND WAS EXPLANTED.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9533093 ↗InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), PATIENT EXPERIENCED INFLAMMATION, PAIN AND LIGHT SWELLING AND IT WAS OBSERVED THAT IMPLANT FAILED TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation; Pain; Swelling
MAUDE report 8987147 ↗
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