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simply ReActive® Implant 754716URecalls & reported problems

Implant Direct Sybron Manufacturing LLC · 4.7mmD x 16mmL, 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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307108177), received between Sep 10, 2019 and Oct 18, 2019 — classified as 2 injuries.

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

  • Failure to Osseointegrate2

Patient problems

  • Failure of Implant2
  • No Consequences Or Impact To Patient1
  • Osteopenia/ Osteoporosis1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 18, 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; No Consequences Or Impact To Patient

    MAUDE report 9207888 ↗
  • InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate

    PER COMPLAINT (B)(4), DURING THE TIME OF EXTRACTION, PATIENT EXPERIENCED FAILURE OR LOSS OF IMPLANT TO INTEGRATE WITH BONE LOSS AROUND THE IMPLANT.

    Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

    MAUDE report 8979656 ↗

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

Sources and updates

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