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

Model Number PK620744

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Edema (1820)

Event Type  Injury  

Event Description

The patient had to return to the operating surgeon several times due to fluid build up.The device remains implanted.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS; po box 585; 30 south satellite road; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMANCE MATERIALS; po box 585; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: beth pashko ; po box 585; 30 south satellite road; south windsor, CT 06074 ; 8606569450
• MDR Report Key: 8703813
• MDR Text Key: 148164872
• Report Number: 3009582362-2019-00008
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810042033405
• UDI-Public: 00810042033405
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK620744
• Device Lot Number: 202075
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2018
• 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 Outcome(s): Other
• Patient Age: 55 YR