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HTR-PEKK PK623204Recalls & reported problems

Oxford Performance Materials, Inc. · 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 00810023925071), received between Jul 23, 2020 and Jul 23, 2020 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Impaired Healing1

Recent adverse event reports

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

  • InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem

    IMPLANT WAS IMPLANTED AND SUBSEQUENTLY REMOVED 5 DAYS AFTER SURGERY AS PATIENT DEVELOPED SKIN WOUND HEALING PROBLEMS.

    Patient problems: Impaired Healing

    MAUDE report 10314735 ↗

Other Plate, Cranioplasty, Preformed, Non-Alterable devices

All Plate, Cranioplasty, Preformed, Non-Alterable devices →

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