MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIALS, INC. HTR-PEKK; CRANIAL IMLANT, PRODUCT CODE: GXN

Model Number	PK623398
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the healthcare facility needed a new implant due to an infection.

• Brand Name: HTR-PEKK
• Common Device Name: CRANIAL IMLANT, PRODUCT CODE: GXN
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor, ct
• MDR Report Key: 10507898
• Report Number: 3009582362-2020-00009
• Device Sequence Number: 16844947
• Product Code: GXN
• UDI-Device Identifier: 00810023925750
• UDI-Public: 00810023925750
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: PK623398
• Device Lot Number: 209000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other