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

Model Number PK614947

Device Problem Insufficient Information (3190)

Patient Problems Cerebrospinal Fluid Leakage (1772); Discharge (2225)

Event Date 03/02/2014

Event Type  No Answer Provided  

Event Description

The patient received a hemicraniectomy after a automobile hit and run accident while on a moped - (b)(6) 2013.An autologous skull implant was attempted unsuccessfully - (b)(6) 2013.The pk614947 was implanted and during the surgical procedure the patient has a csf leak from a lumbar puncture (after the surgery, the doctor stated that he was happy with the implant fit and space between the implant and the brain) - (b)(6) 2014.The patient was re-admitted to the hospital for fluid drainage from the brain - (b)(6) 2014.The implant was removed - (b)(6) 2014.A blood patch was placed over the site of the lumbar drain - (b)(6) 2014.

• 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 000
• Manufacturer Contact: leigh ayres ; 30 south satellite road; south windsor, CT 06074-0000
• MDR Report Key: 3832250
• MDR Text Key: 19022880
• Report Number: 3009582362-2014-00001
• 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: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PK614947
• Device Lot Number: IG3481M-08F001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2014
• Date Device Manufactured: 02/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 20 YR