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

Model Number PK623370

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/23/2020

Event Type  Injury  

Event Description

Patient had an htr-pekk implant removed to allow for an infection to resolve.Surgeon intends to replace with a new cranioplasty.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE 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: 10679899
• MDR Text Key: 211357519
• Report Number: 3009582362-2020-00011
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810023925705
• UDI-Public: 00810023925705
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK623370
• Device Lot Number: 208976
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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: 16 YR