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

Model Number PK615901

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/26/2015

Event Type  No Answer Provided  

Event Description

The pt has an infection on the scalp and the implant was removed as a precaution.The pt is currently undergoing a course of antibiotics.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT, PRODUCT CODE: GXN
• 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: leigh ayres ; 30 south satellite road; south windsor, CT 06074
• MDR Report Key: 4620966
• MDR Text Key: 5572097
• Report Number: 3009582362-2015-00002
• Device Sequence Number: 1
• Product Code: GXN
• 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: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PK615901
• Device Lot Number: IG4307M-21F001
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/25/2015
• Date Device Manufactured: 02/03/2015
• 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): Required Intervention
• Patient Age: 50 YR