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
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall2 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- APEX 5038-1-080Stryker GmbH · PIN, FIXATION, THREADED48 reports
- Agee Digit Widget® DWD-232Hand Biomechanics Lab Inc · Pin, Fixation, Threaded32 reports
- SPATIAL FRAME 71070720Smith & Nephew, Inc. · PIN, FIXATION, THREADED15 reports
- APEX 5038-2-110Stryker GmbH · PIN, FIXATION, THREADED11 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.