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

Model Number PK621220-B

Device Problem Positioning Problem (3009)

Patient Problems Wound Dehiscence (1154); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932)

Event Date 08/26/2019

Event Type  Injury  

Event Description

According to the reporter there was a revision of a device implanted during a cranioplasty procedure.The device was implanted after expander-use.Implantation was significantly delayed because of an accident.After implantation the skin was dehiscent about 1cm, so that the device could be seen through the skin.Explantation was performed with chrome inflammatory reaction because of a reaction of the subcutaneous fat.Patient's skin expanded after irradiation and chronic wound infection.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS; po box 585; 30 souh satellite 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: 9240823
• MDR Text Key: 164850437
• Report Number: 3009582362-2019-00011
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810042035744
• UDI-Public: 00810042035744
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK621220-B
• Device Lot Number: 203433
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2018
• 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): Other; Required Intervention
• Patient Age: 42 YR