MAUDE Adverse Event Report: MEDCAD ACCUPLAN; ACCUPLAN SYSTEM ORTHOGNATIC TITANIUM GUIDE

Model Number	ZB-KT001
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Experienced guide fit issue when tested on anatomical model prior surgery.

• Brand Name: ACCUPLAN
• Common Device Name: ACCUPLAN SYSTEM ORTHOGNATIC TITANIUM GUIDE
• Manufacturer (Section D): MEDCAD; 501 s. second ave; suite 100; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 3401 technology dr.; unit 3; plano TX 75074
• Manufacturer Contact: vishvani patel ; 501 s. second avenue; suite a-1000; dallas, TX 75226
• MDR Report Key: 22473364
• Report Number: 3009196021-2025-00008
• Device Sequence Number: 20861333
• Product Code: DZJ
• UDI-Device Identifier: 00810007631202
• UDI-Public: (01)00810007631202(10)251588WES
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/10/2025

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: ZB-KT001
• Device Catalogue Number: ZB-KT001
• Device Lot Number: 251588 WES
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• 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: 36 YR
• Patient Sex: Female