SwishPlus® Implant 924106Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10841307106128), received between Oct 30, 2019 and Oct 31, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (K081396); they may or may not involve this specific model.

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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23436681 ↗
• InjuryApr 11, 2024Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION.

  Patient problems: Failure of Implant

  MAUDE report 19091366 ↗
• InjuryMay 11, 2023Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 16912509 ↗
• InjuryDec 29, 2021Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT 78023, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 13108112 ↗
• InjuryJan 25, 2021Contamination; Contamination

  PER (B)(4), CLAIM FORM RECEIVED WITH MISSING INFORMATION, CONTACTED CUSTOMER FOR ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 11222971 ↗
• InjuryDec 2, 2020Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 10934441 ↗
• InjuryOct 14, 2020Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 10676100 ↗
• InjuryDec 30, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Edema; Failure of Implant; Pain; Unspecified Infection

  MAUDE report 9529382 ↗
• 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 9464645 ↗
• InjuryOct 30, 2019Failure 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; Osteopenia/ Osteoporosis

  MAUDE report 9254567 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081396. One submission often covers many models, so check the product and lot details in each record.

• Z-1126-2020 · Jan 9, 2019 · Terminated
  SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
• Z-1168-2018 · Jan 19, 2018 · Terminated
  SwishPlus Implant Intended for use in support for fixed bridgework.
• Z-0396-2016 · Oct 28, 2015 · Terminated
  DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable