Skip to content

simply ReActive® Implant 754708URecalls & reported problems

Implant Direct Sybron Manufacturing LLC · 4.7mmD x 8mmL, 4.3mmD Platform · Class 2 · Implant

All models of simply ReActive Implant (17)

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

Adverse event reports
11
Deaths reported
0
Injuries reported
11
Recalls naming it
0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10841307108139), received between Aug 21, 2019 and Apr 20, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (9 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 Osseointegrate9
  • Loss of Osseointegration2

Patient problems

  • Failure of Implant11
  • No Consequences Or Impact To Patient5
  • Inflammation3
  • Osteopenia/ Osteoporosis3
  • Unspecified Infection2
  • Fibrosis1
  • Hyperplasia1
  • Pain1

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 20, 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; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection

    MAUDE report 16775685 ↗
  • InjuryNov 24, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant; Fibrosis; Osteopenia/ Osteoporosis

    MAUDE report 15860394 ↗
  • InjuryDec 14, 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; Inflammation; Osteopenia/ Osteoporosis

    MAUDE report 13006927 ↗
  • InjuryFeb 25, 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; No Consequences Or Impact To Patient

    MAUDE report 9749014 ↗
  • InjuryFeb 14, 2020Loss of Osseointegration; Loss of Osseointegration

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

    Patient problems: Failure of Implant; Hyperplasia

    MAUDE report 9710655 ↗
  • InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate

    PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE DUE TO INFECTION.

    Patient problems: Failure of Implant; Inflammation; Unspecified Infection

    MAUDE report 9022366 ↗
  • 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 8987263 ↗
  • InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant; No Consequences Or Impact To Patient

    MAUDE report 8987109 ↗
  • InjurySep 9, 2019Failure to Osseointegrate; Failure to Osseointegrate

    PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. NO PATIENT IMPACT WAS REPORTED.

    Patient problems: Failure of Implant; No Consequences Or Impact To Patient

    MAUDE report 8977956 ↗
  • InjurySep 9, 2019Failure to Osseointegrate; Failure to Osseointegrate

    PER COMPLAINT (B)(4), IMPLANT FAILED TO INTEGRATE. NO PATIENT IMPACT WAS REPORTED.

    Patient problems: Failure of Implant; No Consequences Or Impact To Patient

    MAUDE report 8977953 ↗
  • InjuryAug 21, 2019Failure to Osseointegrate; Failure to Osseointegrate

    PER COMPLAINT (B)(4), PATIENT HAD EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE. PATIENT REPORTED WITH LOOSE IMPLANT AND IMPLANT WAS PULLED OUT BY THE PATIENT.

    Patient problems: Failure of Implant; Pain

    MAUDE report 8914101 ↗

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page