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

Model Number	ZB-SPK20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Cranial device explant due to patient's continued growing tumor post-operatively.Implant to be explanted and replaced following additional surgical defect removal.

• Brand Name: ACCUSHAPE
• Common Device Name: PEEK PATIENT-SPECIFIC 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: 22913825
• Report Number: 3009196021-2025-00012
• Device Sequence Number: 9055129
• Product Code: GXN
• UDI-Device Identifier: 00810007630618
• UDI-Public: (01)00810007630618(10)240717CAR
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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: ZB-SPK20
• Device Catalogue Number: ZB-SPK20
• Device Lot Number: 240717CAR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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: 64 YR
• Patient Sex: Female