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

Model Number	PK623786
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pk623786 was shipped for a planned surgery date of (b)(6) 2020.On (b)(6) 2023, opm received a new request for an implant for the same patient and the ct scan showed the previous implant was still implanted fractured into multiple pieces.It is unknown how long after implantation, or how, the implant fractured.
Event or Problem Description
Cranial implant pk623786 fractured post-implantation.However, the cause and date of fracture is unknown.

• 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: 16499637
• Report Number: 3009582362-2023-00002
• Device Sequence Number: 20407337
• Product Code: GXN
• UDI-Device Identifier: 00810023927983
• UDI-Public: (01)00810023927983(10)209730
• 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): 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PK623786
• Device Lot Number: 209733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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