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simply ReActive® Implant 755711URecalls & reported problems

Implant Direct Sybron Manufacturing LLC · 5.7mmD x 11.5mmL, 5.0mmD 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
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307108207), received between Oct 30, 2019 and Sep 30, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Positioning Failure” (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

  • Positioning Failure2
  • Failure to Osseointegrate1

Patient problems

  • Failure of Implant3
  • Fibrosis1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2021Positioning Failure; Positioning Failure

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

    Patient problems: Failure of Implant

    MAUDE report 12553589 ↗
  • InjuryJul 27, 2021Positioning Failure; Positioning Failure

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

    Patient problems: Failure of Implant

    MAUDE report 12232490 ↗
  • InjuryOct 30, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant; Fibrosis

    MAUDE report 9254554 ↗

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

Sources and updates

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