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HTR-PEKK PK619609Recalls & 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 00813298028546), received between Oct 13, 2017 and Oct 13, 2017 — 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.

  • InjuryOct 13, 2017Adverse Event Without Identified Device or Use Problem

    THE IMPLANT WAS REMOVED DUE TO AN INFECTION. THE TYPE AND CAUSE/SOURCE OF THE INFECTION ARE UNKNOWN. THE IMPLANT IS SHIPPED NON-STERILE AND STERILIZED AT THE HOSPITAL/HEALTHCARE FACILITY ACCORDING TO THE INSTRUCTIONS FOR USE. THERE ARE NO STERILIZATION, PATHOLOGY OR SURGICAL RECORDS AVAILABLE AT THIS TIME. THE IMPLANT WAS DISCARDED AFTER REMOVAL.

    Patient problems: Unspecified Infection

    MAUDE report 6949530 ↗

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.