HTR-PEKK PK624272Recalls & 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 00810077240441), received between Jul 21, 2021 and Jul 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Decoupling” (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
- Decoupling1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2021Decoupling
IT WAS REPORTED THAT THE SURGEON HAD ISSUES WITH THE 3.5MM THICK IMPLANT. SURGEON ATTEMPTED TO PLACE A FIXATION DEVICE WITHOUT PREDRILLING APPROXIMATELY 4-5MM FROM THE EDGE AND THE IMPLANT CRACKED AND A SECTION OF THE IMPLANT CHIPPED OFF. SURGEON PREDRILLED REMAINING SCREW HOLES BUT ONE SCREW HOLE STILL RESULTED IN A HAIRLINE CRACK WHEN THE SCREW WAS TIGHTED ALL THE WAY DOWN. SURGEON WAS GENTLE IN PLACING DEVICE AND SECURING HARDWARE AND SURGERY WAS ULTIMATELY COMPLETED WITH THE DEVICE AS-IS.
Patient problems: Insufficient Information
MAUDE report 12207371 ↗
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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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