MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIAL, INC. HTR-PEKK; CRANIAL IMPLANT

Model Number PK615906

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Fluid Discharge (2686)

Event Date 11/25/2014

Event Type  No Answer Provided  

Event Description

Explanted due to pain and discharge.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIAL, INC.; 30 south satellite road; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMACNE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: leigh ayres ; 30 south satellite road; south windsor, CT 06074 ; 8606989300
• MDR Report Key: 4379956
• MDR Text Key: 5288845
• Report Number: 3009582362-2014-00006
• 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: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PK615906
• Device Catalogue Number: NONE
• Device Lot Number: IG4120M-10F001
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2014
• Date Device Manufactured: 11/13/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR