simplyInterActive® DRIVER HT2.7LGRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307119876), received between Mar 25, 2019 and Jun 18, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
Device problems
- Detachment of Device or Device Component1
- Positioning Failure1
Patient problems
- Failure of Implant1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2021Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.
Patient problems: Failure of Implant
MAUDE report 12024355 ↗MalfunctionMar 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
PER COMPLAINT (B)(4), THE HAND DRIVER BECAME STUCK INSIDE OF TWO SEPARATE IMPLANTS, RESULTING IN THE IMPLANTS REMOVAL. THIS COMPLAINT IS FOR THE TOOL ASSOCIATED WITH 3500A 3001617766-2019-00059 AND 3001617766-2019-00060.
Patient problems: No Information
MAUDE report 8449996 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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