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AXS 56-19005Recalls & reported problems

Stryker Leibinger GmbH & Co. KG · BONE SCREWS,EMERG.,AXS,SELF-TAP. · 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 37613327358446), received between Jun 7, 2019 and Jun 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1
  • Loose or Intermittent Connection1

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.

  • InjuryJun 7, 2019Loose or Intermittent Connection; Device Dislodged or Dislocated

    IT WAS REPORTED THAT FOLLOWING BI-LATERAL MANDIBLE DISTRACTION SURGERY, THE LEFT DISTRACTOR REMAINED IN PLACE, BUT THE RIGHT DISTRACTOR PLATE CAME OFF THE BONE. THE PLATE WAS INTACT, BUT THE SCREWS HAD LOOSENED. A REVISION SURGERY WILL BE DONE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8680725 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

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