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DISTRACTION, INTERNAL 51-430-95-07Recalls & reported problems

KLS-Martin L.P. · PATIENT SCREWDRIVER, HEX, 0.3 MM PER TURN, BLUE · Class 1

All models of DISTRACTION, INTERNAL (67)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00888118081445), received between Oct 7, 2021 and Oct 7, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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 18, 2026.

Most reported problems

Device problems

  • Human-Device Interface Problem1
  • Use of Device Problem1

Patient problems

  • Skull Fracture1

Recent adverse event reports

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

  • InjuryOct 7, 2021Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem

    IT WAS REPORTED THAT AN INCORRECT SCREWDRIVER WAS USED WITH IMPLANTED MANDIBULAR DISTRACTORS IN A CRANIAL PROCEDURE.

    Patient problems: Skull Fracture

    MAUDE report 12593930 ↗

Other SCREWDRIVER devices

All SCREWDRIVER devices →

Sources and updates

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