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simplyInterActive® DRIVER HD2.7SGRecalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1

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 10841307119944), received between Feb 7, 2022 and May 16, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Defective Device” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Defective Device1
  • Material Deformation1
  • Separation Failure1

Patient problems

  • Failure of Implant3
  • Insufficient Information1

Recent adverse event reports

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

  • InjuryMay 16, 2023Defective Device; Defective Device

    PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

    Patient problems: Failure of Implant

    MAUDE report 16937019 ↗
  • InjuryJun 7, 2022Separation Failure; Separation Failure

    PER COMPLAINT (B)(4), BEFORE CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.

    Patient problems: Failure of Implant

    MAUDE report 14621337 ↗
  • InjuryFeb 7, 2022Material Deformation; Material Deformation

    PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURE WAS OBSERVED.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 13472241 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.