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HTR-PEKK PK625635Recalls & 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 00810077248515), received between Mar 7, 2023 and Mar 7, 2023 — 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

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CASE SALES REP INFORMED OPM THAT THE IMPLANT HAD TO BE EXPLANTED DUE TO AN INFECTION IN THE PATIENT. THE REP CONFIRMED THAT THE INFECTION WAS DUE TO PATIENT NON-COMPLIANCE. THE SURGEON REQUESTED AN EXACT REPLICA OF THE INITIAL IMPLANT AS A REPLACEMENT. IMPLANTATION AND EXPLANTATION DATES ARE NOT KNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 16499649 ↗

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.