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HTR-PEKK PK620653Recalls & 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 00810042032965), received between May 1, 2018 and May 1, 2018 — classified as 1 malfunction.

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

  • Fracture1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • MalfunctionMay 1, 2018Fracture

    THE DISTRIBUTOR REPORTED WHILE THE SURGEON WAS ATTEMPTING TO PRE-PLATE THE IMPLANT AWAY FROM THE PATIENT, THE IMPLANT FRACTURED WHEN THE SURGEON ATTEMPTED TO INSERT THE SCREWS. THE DISTRIBUTOR STATED THE SURGEON DID NOT PRE-DRILL, AND A MANUAL DRIVER WAS USED. THERE WAS NO INJURY. THERE WAS A DELAY OF APPROXIMATELY 20 MINUTES WHILE THE PATIENT'S NATIVE BONE FLAP WAS RETRIEVED. THE PATIENT'S NATIVE BONE FLAP WAS USED TO COMPLETE THE PROCEDURE.

    Patient problems: Failure of Implant

    MAUDE report 7475257 ↗

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.