HTR-PEKK PK619467Recalls & 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 00813298028041), received between Nov 3, 2017 and Nov 3, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
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.
InjuryNov 3, 2017Contamination
THE IMPLANT WAS REMOVED DUE TO AN INFECTION. THE SALES ASSOCIATE STATED THE PATIENT HAS A THICK SCALP & THE SURGEON HAD DIFFICULTY STRETCHING THE SKIN OVER THE IMPLANT, WHICH THE SURGEON BELIEVES MAY HAVE CONTRIBUTED TO THE ISSUE. THERE IS NO KNOWN HISTORY OF INFECTION AT THE HOSPITAL AND THE STERILIZATION RECORDS ARE NOT AVAILABLE. THE TYPE AND CAUSE/SOURCE OF THE INFECTION ARE UNKNOWN. THE IMPLANT WAS DISCARDED AFTER REMOVAL.
Patient problems: Unspecified Infection
MAUDE report 7000400 ↗
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- IPS 60-000-23-09KLS-Martin L.P. · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE7 reports
- NA SD800.540Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE6 reports
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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