HTR-PEKK PK621096Recalls & 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 00810042034914), received between Sep 18, 2018 and Sep 18, 2018 — 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

Cerebrospinal Fluid Leakage1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem
THE SALES ASSOCIATE REQUESTED A RE-MAKE OF PK621096 DUE TO A RE-OPERATION. THE PATIENT HAD A CSF LEAK DUE TO DAMAGE TO THE DURA. UPON FOLLOW-UP WITH THE SALES ASSOCIATE, IT WAS CONFIRMED THAT THERE WAS NO ALLEGED FAILURE OF THE IMPLANT TO PERFORM AS INTENDED AND NO INDICATION THAT THE IMPLANT CONTRIBUTED TO THE NEED FOR THE RE-OPERATION. DURING THE ORIGINAL IMPLANT PROCEDURE ON (B)(6) 2018 IT WAS NOTED THAT THE PATIENT'S DURA WAS NOT INTACT.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 7884936 ↗

Device details

UDI-DI	`00810042034914`
Brand	HTR-PEKK
Model	PK621096
Company	Oxford Performance Materials, Inc.
Product code	GXN · Plate, Cranioplasty, Preformed, Non-Alterable
Class	Class 2
FDA submission	K121818
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 8, 2021

Device type (GMDN): Custom-made cranial bone prosthesis

An implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.

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All Plate, Cranioplasty, Preformed, Non-Alterable devices →

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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