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

Model Number PK623628

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/06/2020

Event Type  Injury  

Event 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
• Type of Device: CRANIAL IMPLANT, PRODUCT CODE: GXN
• Manufacturer (Section D): OXFORD PERFORMANE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: james porteus ; 30 south satellite road; south windsor, CT 06074 ; 8606569438
• MDR Report Key: 10992364
• MDR Text Key: 220961155
• Report Number: 3009582362-2020-00012
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810023927044
• UDI-Public: 00810023927044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK623628
• Device Lot Number: 209453
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR