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HTR-PEKK PK624289Recalls & 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 00810077240588), received between Sep 10, 2021 and Sep 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fitting Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionSep 10, 2021Fitting Problem

    IT WAS REPORTED THAT THE SURGEON EXPERIENCED ISSUES WITH THE DEVICE FITTING DURING SURGERY WHICH REQUIRED SIGNIFICANT BURRING TO ACHIEVE AN ADEQUATE FIT. A LARGE PORTION OF THE POSTERIOR AND INFERIOR EDGES OF THE IMPLANT WAS REMOVED INTRAOPERATIVELY. DURING PLATING, THE IMPLANT CRACKED AROUND THE SCREW HOLE. SURGEON COMPLETED SURGERY WITH THE DEVICE AS-IS.

    Patient problems: Insufficient Information

    MAUDE report 12456668 ↗

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.