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

Model Number	PK623033
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant was reordered.Distributor believes the purpose of the reorder is to replace the original device due to patient infection but noted there were no issues with the implant itself and that the patient had an unrelated infection in the scalp near the surgical site.

• Brand Name: HTR-PEKK
• Common Device Name: CRANIAL IMPLANT, PRODUCT CODE: GXN
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor, ct
• MDR Report Key: 10409829
• Report Number: 3009582362-2020-00007
• Device Sequence Number: 3257024
• Product Code: GXN
• UDI-Device Identifier: 00810023924241
• UDI-Public: 00810023924241
• 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): 08/14/2020

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: PK623033
• Device Lot Number: 208101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 08/14/2020
• 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