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

Model Number PK621045

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Event Description

According to the reporter, the implant was being removed from the patient.The patient was having scalp issues due to tightness and the skin eventually opened up.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS; po box 585; 30 souh satelliet road; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMACE MATERIALS; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: beth pashko ; 30 south satellite road; south windsor, CT 06074 ; 8606569450
• MDR Report Key: 8440906
• MDR Text Key: 139472100
• Report Number: 3009582362-2019-00004
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK621045
• Device Lot Number: 202767
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other