HTR-PEKK PK624890Recalls & 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 00810077244173), received between May 20, 2022 and May 20, 2022 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem
ZB INFORMED US THAT THE SALES REP ASKED IF WE COULD REMAKE PK624890 DUE TO THE PATIENT'S SKIN REOPENING NEAR THE IMPLANT. REP INFORMED ZB COORDINATOR THAT THAT THEY DON'T BELIEVE IT HAS TO DO WITH THE IMPLANT ITSELF. PK624890 WAS DONE WITH A "JOHN DOE" NAME, BUT THE HOSPITAL NOW KNOWS THE PATIENT'S NAME AND WISHES TO HAVE THE PATIENT'S REAL NAME ON THE LABEL AND TO HAVE A NEW PART NUMBER. BUT, THEY ARE ASKING FOR THE EXACT SAME DESIGN.
Patient problems: Unspecified Tissue Injury
MAUDE report 14459128 ↗
Other Plate, Cranioplasty, Preformed, Non-Alterable devices
- NA SD800.440Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE22 reports
- AccuShape® MC-SPK30Medcad · Plate, Cranioplasty, Preformed, Non-Alterable13 reports
- AccuShape® MC-SPK40Medcad · Plate, Cranioplasty, Preformed, Non-Alterable13 reports
- NA SD800.434Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE11 reports
- NA SD800.427Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE8 reports
- NA SD800.433Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE8 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page