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Screw Removal Tool SXTRecalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307119487), received between Sep 26, 2022 and Sep 26, 2022 — classified as 1 injury.

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

Most reported problems

Device problems

  • Fracture1

Patient problems

  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 26, 2022Fracture; Fracture

    PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, THE HEX DRILL STUCK IN THE HEAL ABUTMENT.

    Patient problems: Failure of Implant

    MAUDE report 15485817 ↗

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