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SMARTLOCK 55-02950Recalls & reported problems

Stryker Leibinger GmbH & Co. KG · Hybrid MMF Plate · 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 34546540732072), received between Jun 28, 2018 and Jun 28, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Align” (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

  • Failure to Align1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryJun 28, 2018Failure to Align

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A PATIENT HAD EXPERIENCED A MISALIGNED OCCLUSION AFTER A PROCEDURE. A REVISION SURGERY WAS PERFORMED IN ORDER TO CORRECT THE ISSUE.

    Patient problems: No Code Available

    MAUDE report 7647896 ↗

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.