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NA 50-20906Recalls & reported problems

Stryker Leibinger GmbH & Co. KG · Bone Screws, Cross-Pin, MP,self-drilling · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 34546540602993), received between Nov 24, 2020 and Nov 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Device Appears to Trigger Rejection1

Patient problems

  • Erythema1
  • Fluid Discharge1
  • Foreign Body Reaction1

Recent adverse event reports

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

  • InjuryNov 24, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    THE PATIENT HAD A MANDIBULAR FRACTURE, AND TWO PLATES AND THEIR ASSOCIATED BONE SCREWS WERE USED DURING THE PROCEDURE. POST-OPERATIVELY THE PATIENT PRESENTED REPEATED SUBMENTAL REDNESS AND EXUDATION, AND SHOWED NO SIGNIFICANT IMPROVEMENT AFTER 1 MONTH OF TREATMENT WITH ANTI-INFLAMMATORY MEDICATIONS AND LOCAL DRESSING CHANGES. AS A RESULT, THE PATIENT HAD THE PLATES AND SCREWS EXPLANTED. THERE IS NO INDICATION THAT THE IMPLANTS DID NOT ACT AS INTENDED.

    Patient problems: Erythema; Fluid Discharge; Foreign Body Reaction

    MAUDE report 10896786 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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