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

Model Number	PK624890
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Zb informed us that the sales rep asked if we could remake pk624890 due to the patient's skin reopening near the implant.Rep informed zb coordinator that that they don't believe it has to do with the implant itself.Pk624890 was done with a "john doe" name, but the hospital now knows the patient's name and wishes to have the patient's real name on the label and to have a new part number.But, they are asking for the exact same design.

• Brand Name: HTR-PEKK
• Common Device Name: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• Manufacturer (Section G): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• Manufacturer Contact: james porteus ; 30 south satellite road; south windsor, CT 06074 ; 8606569438
• MDR Report Key: 14459128
• Report Number: 3009582362-2022-00005
• Device Sequence Number: 17292382
• Product Code: GXN
• UDI-Device Identifier: 00810077244173
• UDI-Public: (01)00810077244173(10)211106
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PK624890
• Device Lot Number: 211106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown