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APEX 5038-2-080Recalls & 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 07613327091779), received between Mar 31, 2020 and Mar 31, 2020 — classified as 1 malfunction.

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

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMar 31, 2020Fracture; Fracture

    AS REPORTED: "FACIAL TRAUMA, EXTERNAL FIXATION. PIN FRACTURED OFF WHILE FIXATING TO BONE. ONLY 2 THREADS INTO BONE AND REST OF PIN WAS STUCK IN HANDLE. DR WAS ABLE TO "CHUCK" THE BIT OF BONE OUT OF THE BONE. CASE ENDED SUCCESSFULLY." ADDITIONALLY REPORTED: "PIN WAS USED FOR A MANDIBLE FRACTURE. EX FIX ON THE PATIENTS RIGHT".

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9907921 ↗

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.