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APEX 5017-4-180SRecalls & reported problems

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154493333), received between Dec 6, 2018 and Dec 6, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

  • Fracture2

Patient problems

  • Foreign Body In Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 6, 2018Fracture

    AS REPORTED ON MEDWATCH (B)(4) : "DURING A SURGICAL PROCEDURE REMOVAL EXTERNAL FIXATOR OF THE RIGHT LEG, REMOVAL OF THE FRAME THE TWO ANTERIOR PINS HAD FRACTURED AT THE BONE INTERFACE HALF OF THE PINS WAS STILL REMAINING INSIDE THE FEMUR, BURIED". ORIGINAL INTENDED PROCEDURE: REMOVAL OF EXTERNAL FIXATOR OF THE RIGHT LEG.

    Patient problems: Foreign Body In Patient

    MAUDE report 8139819 ↗
  • InjuryDec 6, 2018Fracture

    AS REPORTED ON MEDWATCH (B)(4): "DURING A SURGICAL PROCEDURE REMOVAL EXTERNAL FIXATOR OF THE RIGHT LEG, REMOVAL OF THE FRAME THE TWO ANTERIOR PINS HAD FRACTURED AT THE BONE INTERFACE HALF OF THE PINS WAS STILL REMAINING INSIDE THE FEMUR, BURIED". ORIGINAL INTENDED PROCEDURE: REMOVAL OF EXTERNAL FIXATOR OF THE RIGHT LEG.

    Patient problems: Foreign Body In Patient

    MAUDE report 8139814 ↗

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.