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Kyocera Medical Technologies, Inc. Tesera (REF 1028-003-001)Recalls & reported problems

Kyocera Medical Technologies, Inc. · Locking Cover Plate · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00841523100019), received between Dec 21, 2021 and Dec 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 18, 2026.

Most reported problems

Device problems

  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionDec 21, 2021Mechanical Problem; Mechanical Problem

    THE COVER PLATE HAS DISENGAGED FROM THE CAGE AS SEEN IN 3 AND 6 WEEKS POST-OP IMAGING. THE CENTER POST OF THE COVER PLATE IS SLIGHTLY PROUD OF THE FRONT OF THE COVER PLATE FOR THE ASSEMBLY. NO REVISION CASE HAS BEEN SCHEDULED AND NO HARM HAS BEEN CAUSED TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13056886 ↗

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Sources and updates

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