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NA 21-20358Recalls & reported problems

Stryker Leibinger GmbH & Co. KG · MMF SCREW, CROSS-PIN, SELF DRILLING · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154716289), received between Sep 13, 2023 and Sep 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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

  • Loosening of Implant Not Related to Bone-Ingrowth1
  • Migration1

Patient problems

  • Discomfort1

Recent adverse event reports

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

  • MalfunctionSep 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

    IT WAS REPORTED THAT THE CUSTOMER FOUND THE MMF SCREWS WERE LOOSE AS IF THEY ERE NOT HOLDING IN PLACE. IT IS NOT KNOWN AT THIS TIME IF THERE WILL BE OR HAS BEEN A REVISION SURGERY TO FIX THE LOOSE SCREWS. NO OTHER INFORMATION IS KNOWN AT THIS TIME.

    Patient problems: Discomfort

    MAUDE report 17740852 ↗

Other SCREW, FIXATION, INTRAOSSEOUS devices

All SCREW, FIXATION, INTRAOSSEOUS devices →

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