Skip to content

HTR-PEKK PK618442Recalls & reported problems

Oxford Performance Materials, Inc. · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813298024494), received between Jan 17, 2017 and Jan 17, 2017.

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

  • Failure of Implant1
  • Unspecified Infection1

Recent adverse event reports

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

  • Jan 17, 2017Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Failure of Implant; Unspecified Infection

    MAUDE report 6255602 ↗

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.