Skip to content

HTR-PEKK PK620239Recalls & 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 00810042031043), received between Feb 14, 2018 and Feb 14, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Operates Differently Than Expected1

Patient problems

  • No Information1

Recent adverse event reports

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

  • InjuryFeb 14, 2018Device Operates Differently Than Expected

    THE SURGEON CONTACTED A SALES ASSOCIATE SEEKING TRENDING INFORMATION FOR FLUID BUILD-UP AROUND PEKK IMPLANTS. THE SURGEON HAS A PATIENT, IDENTIFIED DURING A POST-OPERATIVE FOLLOW UP APPOINTMENT, WHO IS EXPERIENCING FLUID ACCUMULATION AROUND THE IMPLANT. THE SURGEON DOES NOT SUSPECT THIS IS DUE TO AN INFECTION, AND DOES NOT PLAN TO REMOVE THE IMPLANT, BUT WILL MONITOR THE CONDITION.

    Patient problems: No Information

    MAUDE report 7271368 ↗

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.