HTR-PEKK PK622132Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810042039773), received between Feb 4, 2020 and Feb 4, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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
- Microbial Contamination of Device1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2020Microbial Contamination of Device
THE IMPLANT WAS RE-MANUFACTURED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9664987 ↗
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- IPS 60-000-23-09KLS-Martin L.P. · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE7 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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