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

Model Number PK616408

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/15/2015

Event Type  No Answer Provided  

Event Description

Due to an infection, the implant was removed, the area was debrided, and then the implant was re-implanted.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS; 30 south satellite road; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMANCE MATERIALS; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: leigh ayres ; 30 south satellite road; south windsor, CT 06074 ; 8606569414
• MDR Report Key: 4780157
• MDR Text Key: 5820740
• Report Number: 3009582362-2015-00004
• 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: 05/15/2015

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: PK616408
• Device Lot Number: 1G4464M-10F001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/15/2015
• Date Device Manufactured: 03/22/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR