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APEX 5038-2-080SRecalls & reported problems

Stryker GmbH · Self-drilling Half Pin · Class 2 · Implant

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 04546540435392), received between Dec 19, 2016 and Dec 19, 2016 — classified as 1 malfunction.

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

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionDec 19, 2016Break

    DURING SURGERY, THE TIP OF THE PIN BROKE WHEN THE SURGEON WAS INSERTING IT TO THE PATIENT. THE TIP OF THE PIN IS REMAINED TO THE PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 6185331 ↗

Other PIN, FIXATION, THREADED devices

All PIN, FIXATION, THREADED devices →

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