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

Model Number PK621096

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Event Description

The sales associate requested a re-make of pk621096 due to a re-operation.The patient had a csf leak due to damage to the dura.Upon follow-up with the sales associate, it was confirmed that there was no alleged failure of the implant to perform as intended and no indication that the implant contributed to the need for the re-operation.During the original implant procedure on (b)(6) 2018 it was noted that the patient's dura was not intact.

• 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: 7884936
• MDR Text Key: 120539164
• Report Number: 3009582362-2018-00007
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810042034914
• UDI-Public: 00810042034914
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK621096
• Device Lot Number: 202933-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2018
• 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: 60 YR