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PROFYLE 59-23022Recalls & reported problems

Stryker GmbH · BONE SCREWS, CROSS-FIT, SELF-TAPPING · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34546540244988), received between Dec 13, 2022 and Dec 13, 2022 — classified as 1 injury.

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
  • Fracture1

Patient problems

  • Failure of Implant1
  • 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.

  • InjuryDec 13, 2022Break; Fracture; Break; Fracture

    AS REPORTED: "ON (B)(6) 2021, THE PATIENT CAME TO OUR HOSPITAL FOR INTERNAL FIXATION OF THE FRACTURE DUE TO THE FIRST METATARSAL FRACTURE OF THE LEFT FOOT. AFTER THAT, THE PATIENT RECOVERED WELL. ON (B)(6) 2022, THE PATIENT'S X-RAY REEXAMINATION SHOWED THAT THE SCREW WAS BROKEN, AND THE PATIENT HAD NO OBVIOUS DISCOMFORT. ON (B)(6) 2022, A SURGERY WAS PERFORMED TO TAKE THE SCREW OUT, BUT THE BROKEN SCREW COULD NOT BE REMOVED AND RETAINED IN THE BONE."

    Patient problems: Failure of Implant; Foreign Body In Patient

    MAUDE report 15965862 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

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