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

Model Number	PK620239
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS; po box 585; 30 south satellite road; south windsor CT 06074
• MDR Report Key: 7271368
• Report Number: 3009582362-2018-00001
• Device Sequence Number: 16173883
• Product Code: GXN
• UDI-Device Identifier: 00810042031043
• UDI-Public: 00810042031043
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: PK620239
• Device Lot Number: 201136-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 68 YR