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

Model Number	PK623628
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant was reordered to replace device that was or will be removed due to a bleed of some sort.No additional information is available at this time.

• Brand Name: HTR-PEKK
• Common Device Name: CRANIAL IMPLANT, PRODUCT CODE: GXN
• Manufacturer (Section D): OXFORD PERFORMANE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• MDR Report Key: 10992364
• Report Number: 3009582362-2020-00012
• Device Sequence Number: 19789079
• Product Code: GXN
• UDI-Device Identifier: 00810023927044
• UDI-Public: 00810023927044
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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: PK623628
• Device Lot Number: 209453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR