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HTR-PEKK PK620744Recalls & 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 00810042033405), received between Jun 17, 2019 and Jun 17, 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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Edema1

Recent adverse event reports

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

  • InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAD TO RETURN TO THE OPERATING SURGEON SEVERAL TIMES DUE TO FLUID BUILD UP. THE DEVICE REMAINS IMPLANTED.

    Patient problems: Edema

    MAUDE report 8703813 ↗

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.