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HTR-PEKK PK624216Recalls & 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 00810077240212), received between Jul 21, 2021 and Jul 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (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

  • Melted1

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.

  • MalfunctionJul 21, 2021Melted

    IT WAS REPORTED THAT THE IMPLANT MATERIAL MELTED WHEN THE SURGEON ATTEMPTED TO DRILL CONVERGENT HOLES INTO THE IMPLANT TO TACK DOWN THE TEMPORALIS MUSCLE. REPORTER NOTED THE DRILL WAS MEDTRONIC BRAND AND HAD A LARGE DIAMETER - "ALMOST A BURR SIZE" - AND THAT THE CONGEALING CLOSED THE HOLES THE SURGEON HAD JUST DRILLED AND THE SURGEON HAD TO RE-DRILL SEVERAL TIMES DELICATELY SO THIS WOULDN'T HAPPEN. DEVICE REMAINS IMPLANTED.

    Patient problems: Insufficient Information

    MAUDE report 12207381 ↗

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.