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HTR-PEKK PK621416Recalls & 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 00810042038134), received between Apr 3, 2019 and Apr 3, 2019 — 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
  • Detachment of Device or Device Component1

Patient problems

  • No Known Impact Or Consequence 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 3, 2019Break; Detachment of Device or Device Component

    A PIECE OF THE IMPLANT BROKE OFF WHILE THE SURGEON WAS TRYING TO PLACE THE IMPLANT INTO THE PATIENT. THE SURGEON WAS ABLE TO PUT A SCREW THROUGH THE PIECE THAT BROKE OFF TO IMPLANT IT INTO THE PATIENT SEPARATELY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8479206 ↗

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Sources and updates

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