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simply ReActive® Implant 753710URecalls & reported problems

Implant Direct Sybron Manufacturing LLC · 3.7mmD x 10mmL, 3.5mmD 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
7
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10841307108047), received between Sep 10, 2019 and Jun 18, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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 Osseointegrate4
  • Loss of Osseointegration2
  • Positioning Failure1

Patient problems

  • Failure of Implant7
  • Osteopenia/ Osteoporosis4
  • Fibrosis2
  • No Consequences Or Impact To Patient2
  • Inflammation1
  • Insufficient Information1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 18, 2021Positioning Failure; Positioning Failure

    PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

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

    MAUDE report 12024330 ↗
  • InjuryOct 12, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 10662691 ↗
  • InjuryDec 20, 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; No Consequences Or Impact To Patient

    MAUDE report 9501840 ↗
  • InjuryDec 20, 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; Fibrosis; Inflammation; Osteopenia/ Osteoporosis

    MAUDE report 9501782 ↗
  • InjuryOct 25, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

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

    MAUDE report 9237407 ↗
  • InjurySep 10, 2019Loss of Osseointegration; Loss of Osseointegration

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

    Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

    MAUDE report 8979705 ↗
  • InjurySep 10, 2019Loss of Osseointegration; Loss of Osseointegration

    PER COMPLAINT: (B)(4), DURING POST OPERATIVE CHECK PATIENT EXPERIENCED BONE LOSS AROUND THE IMPLANT AND IMPLANT WAS REMOVED

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

    MAUDE report 8979457 ↗

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

Sources and updates

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