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HTR-PEKK PK619160Recalls & 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813298026719), received between Apr 5, 2017 and Apr 5, 2017 — classified as 1 malfunction.

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

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionApr 5, 2017Break

    THE IMPLANT CHIPPED AT THE EDGE DURING INSERTION OF A SCREW. THE SURGEON WAS ATTEMPTING TO FIXATE A PLATE (1.5.6 HOLE REG DOUBLE ) WITH A 4 MM SCREW AND A "SLIVER" OF THE IMPLANT (APPROXIMATELY 4 MM BY 16 MM) BROKE OFF. THIS OCCURRED AWAY FROM THE PATIENT AND DID NOT CAUSE ANY INJURY OR DELAY IN THE CASE. A DIFFERENT PLATE (1.5 2.3 HOLE RECTANGLE) WAS USED AND THE PART WAS SUCCESSFULLY IMPLANTED. THERE IS NO REVISION PLANNED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6461308 ↗

Other Plate, Cranioplasty, Preformed, Non-Alterable devices

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

Sources and updates

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