MAUDE Adverse Event Report: MEDCAD ACCUSHAPE; PEEK PATIENT-SPECIFIC CRANIAL IMPLANT

Model Number	MC-SPK10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient tumor continued growing post-operatively.Implant to be removed and replaced following additional surgical defect removal.

• Brand Name: ACCUSHAPE
• Common Device Name: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s. second ave; suite a-1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 3401 techonology dr.; unit 3; plano TX 75074
• Manufacturer Contact: vishvani patel ; 501 s. second ave; suite a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 21439787
• Report Number: 3009196021-2025-00003
• Device Sequence Number: 4605858
• Product Code: GXN
• UDI-Device Identifier: 00810007630090
• UDI-Public: (01)00810007630090(10)238609HEN
• 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 Implanted Year: 2023
• 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): 02/19/2025

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-SPK10
• Device Catalogue Number: MC-SPK10
• Device Lot Number: 238609HEN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• 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: 22 YR
• Patient Sex: Female