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CannCompScrew 3.0mm (SelfDrill) L3034Recalls & reported problems

Trimed, INC. · Self-Drill CCScrew LThd 3.0, 34mm · Class 2 · Implant

Data updated Oct 16, 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 00842188103209), received between Apr 27, 2021 and Apr 27, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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

  • Migration1

Patient problems

  • Implant Pain1

Recent adverse event reports

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

  • InjuryApr 27, 2021Migration; Migration

    A TRIMED SALES REPRESENTATIVE REPORTED ON 30 MAR 2021 THAT THE L3034 THAT WAS IMPLANTED IN PATIENT (B)(6) ON (B)(6) 2020 HAD TO BE REMOVED. THE SCREW WAS CAUSING SOME PAIN IN THE BOTTOM OF THE PATIENT'S FOOT WHICH LED TO THE SCREW BEING REMOVED. IT WAS REPORTED THAT THE PATIENT WAS FULLY HEALED FROM THE INITIAL SURGERY IN SEPTEMBER BUT THE SCREW HAD MIGRATED FROM ITS ORIGINAL LOCATION CAUSING THE PAIN. IT WAS ALSO STATED THAT THE SURGEON USED A COUNTERSINK UNDER POWER IN THE ORIGINAL SURGERY, LIKELY CAUSING THE SCREW TO MIGRATE. TRIMED SURGICAL INSTRUMENTS LC-73-0004-014-USA REV F STATES, "TRIMED DRIVER SHAFTS, COUNTERSINKS AND TAPS MUST BE CONNECTED TO A HAND-HELD, MANUALLY OPERATED HANDLE, AND ARE NOT ADVISED TO BE PLACED UNDER POWER EQUIPMENT."

    Patient problems: Implant Pain

    MAUDE report 11735009 ↗

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Sources and updates

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