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HTR-PEKK PK622349Recalls & 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 00810023920700), received between Sep 26, 2019 and Sep 26, 2019 — 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

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjurySep 26, 2019Appropriate Device Problem Term/Code Not Available

    THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 9124721 ↗

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.