simplyInterActive® DRIVER HT2.3LGRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307119838), received between Jul 31, 2020 and Nov 12, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryNov 12, 2020Fracture; Positioning Problem; Fracture; Positioning Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PRODUCT FRACTURED.

  Patient problems: Failure of Implant

  MAUDE report 10828230 ↗
• MalfunctionJul 31, 2020Separation Failure; Separation Failure

  AS PER (B)(4) DURING A CLINICAL PROCEDURE A DENTAL IMPLANTS COMPONENTS COULD NOT BE SEPARATED AND THE IMPLANT WAS REMOVED. THERE WAS 1 PATIENT INVOLVED IN THIS EVENT.

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

  MAUDE report 10351118 ↗