Skip to content

HTR-PEKK PK621220-BRecalls & reported problems

Oxford Performance Materials, Inc. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00810042035744), received between Oct 25, 2019 and Oct 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Positioning Problem1

Patient problems

  • Failure of Implant1
  • Inflammation1
  • Unspecified Infection1
  • Wound Dehiscence1

Recent adverse event reports

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

  • InjuryOct 25, 2019Positioning Problem

    ACCORDING TO THE REPORTER THERE WAS A REVISION OF A DEVICE IMPLANTED DURING A CRANIOPLASTY PROCEDURE. THE DEVICE WAS IMPLANTED AFTER EXPANDER-USE. IMPLANTATION WAS SIGNIFICANTLY DELAYED BECAUSE OF AN ACCIDENT. AFTER IMPLANTATION THE SKIN WAS DEHISCENT ABOUT 1CM, SO THAT THE DEVICE COULD BE SEEN THROUGH THE SKIN. EXPLANTATION WAS PERFORMED WITH CHROME INFLAMMATORY REACTION BECAUSE OF A REACTION OF THE SUBCUTANEOUS FAT. PATIENT'S SKIN EXPANDED AFTER IRRADIATION AND CHRONIC WOUND INFECTION.

    Patient problems: Failure of Implant; Inflammation; Unspecified Infection; Wound Dehiscence

    MAUDE report 9240823 ↗

Other Plate, Cranioplasty, Preformed, Non-Alterable devices

All Plate, Cranioplasty, Preformed, Non-Alterable devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page