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

Model Number	MC-AST40
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Dissection needed to make the implant fit, took longer than expected.

• Brand Name: ACCUSHAPE TITANIUM
• Common Device Name: TITANIUM CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s 2nd ave.; suite a-1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 3401 technology dr.; plano TX 75074
• Manufacturer Contact: vishvani patel ; 501 s 2nd st ave; suite a -1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 25263116
• Report Number: 3009196021-2026-00010
• Device Sequence Number: 13103787
• Product Code: GXN
• UDI-Device Identifier: 00810007631066
• UDI-Public: (01)00810007631066(10)262859FIT
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K220357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC-AST40
• Device Catalogue Number: MC-AST40
• Device Lot Number: 262859FIT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2026
• 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: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male