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simply ReActive® Implant 755710URecalls & reported problems

Implant Direct Sybron Manufacturing LLC · 5.7mmD x 10mmL, 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
8
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10841307108191), received between Aug 28, 2019 and Oct 8, 2021 — classified as 8 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (8 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 Osseointegrate8

Patient problems

  • Failure of Implant8
  • Pain3
  • Inflammation2
  • Osteopenia/ Osteoporosis2
  • Discomfort1
  • No Consequences Or Impact To Patient1
  • Swelling1
  • Unspecified Infection1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 8, 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

    MAUDE report 12598004 ↗
  • InjuryApr 15, 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

    MAUDE report 11670787 ↗
  • InjurySep 30, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

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

    MAUDE report 10605113 ↗
  • InjurySep 24, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

    Patient problems: Failure of Implant; Unspecified Infection

    MAUDE report 10580105 ↗
  • InjuryApr 2, 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; Osteopenia/ Osteoporosis

    MAUDE report 9914831 ↗
  • InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate

    PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, IT WAS OBSERVED THAT PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

    Patient problems: Discomfort; Failure of Implant; Pain

    MAUDE report 9022198 ↗
  • InjurySep 11, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

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

    MAUDE report 8986964 ↗
  • InjuryAug 28, 2019Failure to Osseointegrate; Failure to Osseointegrate

    PER COMPLAINT (B)(4), PATIENT EXPERIENCED FAILURE OR LOSS OF IMPLANT #5 TO INTEGRATE, PAIN AND SWELLING.

    Patient problems: Failure of Implant; Inflammation; Pain; Swelling

    MAUDE report 8943292 ↗

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

Sources and updates

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