MAUDE Adverse Event Report: MEDCAD ACCUSHAPE PEEK; PEEK CRANIAL IMPLANT

Model Number	MC-SPK40
Medical Device Problem Code	Prophylactic removal due to corrective action (4077)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient got an infection that required them to explant the peek implant.
Additional Manufacturer Narrative
It was verified by the sales representative that the peek implant was removed because the patient had a subdural hematoma.The hematoma was not related to the cranioplasty surgery, but a result of a prior surgical complication.

• Brand Name: ACCUSHAPE PEEK
• Common Device Name: PEEK CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s 2nd ave.; suite a - 1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 3401 technology dr.; unit 3; plano TX 75074
• Manufacturer Contact: vishvani patel ; 501 s 2nd ave; suite a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 22444097
• Report Number: 3009196021-2025-00007
• Device Sequence Number: 7425302
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)251625VAL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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: MC-SPK40
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 251625 VAL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 75 KG