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

Model Number	PK623195
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
In (b)(6) 2021, the healthcare facility ordered a duplicate of device pk623195 to replace identical implant they reported was removed in (b)(6) 2020 to treat an infection.This is the same infection event reported under 3009582-2020-00010 related to device pk623206 (bilateral implant case).

• Brand Name: HTR-PEKK
• Common Device Name: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• MDR Report Key: 11924603
• Report Number: 3009582362-2021-00005
• Device Sequence Number: 4381314
• Product Code: GXN
• UDI-Device Identifier: 00810023925026
• UDI-Public: (01)00810023925026(10)208677
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 06/02/2021

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: PK623195
• Device Lot Number: 208677
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR