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PROFYLE 59-23014Recalls & 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 34546540244902), received between Feb 28, 2020 and Feb 28, 2020 — classified as 1 injury.

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

  • Device Embedded In Tissue or Plaque1
  • Injury1

Recent adverse event reports

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

  • InjuryFeb 28, 2020Fracture; Fracture

    AS REPORTED: "ON (B)(6) 2018 FIX TWO METABOLIC FRACTURES USING TWO PROFILE COMBO 2.3MM SCREWS. (NO PLATE USED, TWO SCREWS INSERTED ALONE). WITHDRAWAL OPERATION AFTER HEALING ON (B)(6) 2020 MAKES REMOVAL DIFFICULT. WHEN I TRIED TO REMOVE THE SCREW WITH THE REMOVAL SCREWDRIVER, BOTH HEADS WERE IMMEDIATELY BROKEN. WITHDRAWAL BECAME DIFFICULT, AND THE OPERATION WAS ONCE COMPLETED. ON THE SAME DAY, THE DEALER BROUGHT IN SYNTHES' BROKEN SCREW REMOVAL INSTRUMENT AND RE-OPERATED TO REMOVE ALL IMPLANTS."

    Patient problems: Device Embedded In Tissue or Plaque; Injury

    MAUDE report 9772366 ↗

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.