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

Model Number PK620239

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/29/2018

Event Type  Injury  

Event Description

The surgeon contacted a sales associate seeking trending information for fluid build-up around pekk implants.The surgeon has a patient, identified during a post-operative follow up appointment, who is experiencing fluid accumulation around the implant.The surgeon does not suspect this is due to an infection, and does not plan to remove the implant, but will monitor the condition.

• 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: 7271368
• MDR Text Key: 100118840
• Report Number: 3009582362-2018-00001
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810042031043
• UDI-Public: 00810042031043
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK620239
• Device Lot Number: 201136-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2017
• 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): Life Threatening; Other
• Patient Age: 68 YR