MAUDE Adverse Event Report: MEDCAD ACCUPLATE; PATIENT-SPECIFIC PLATE

Model Number	ZB-3DT041
Medical Device Problem Code	Prophylactic removal due to corrective action (4077)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Medical device site infection (4845)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Left and right mandible plates explanted.

• Brand Name: ACCUPLATE
• Common Device Name: PATIENT-SPECIFIC PLATE
• 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: 24026117
• Report Number: 3009196021-2026-00001
• Device Sequence Number: 9191285
• Product Code: JEY
• UDI-Device Identifier: 00810007632636
• UDI-Public: (01)00810007632636(10)251581DAN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: ZB-3DT041
• Device Catalogue Number: ZB-3DT041
• Device Lot Number: 251581DAN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female