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Stainless Steel Surgical Handle - 2.5mmD SSH2.5Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307119470), received between Sep 7, 2018 and Sep 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation 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

  • Separation Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionSep 7, 2018Separation Problem; Separation Problem

    PER COMPLAINT (B)(4), DURING THE OSTEOTOMY, THE IMPLANT BECAME STUCK MIDWAY. THE DOCTOR WAS UNABLE TO REMOVE THE IMPLANT WITHOUT DAMAGING THE IMPLANT OR INSTRUMENTS. THERE WAS NO ADVERSE IMPACT TO PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7857762 ↗

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Sources and updates

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