MAUDE Adverse Event Report: MEDCAD ACCUPLATE 3DTI; ACCUPLATE 3DTI PATIENT-SPECIFIC PLATE

Model Number	MC-3DT011
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported plates and guides did not fit the patient, but did fit the anatomical models.The complainant informed medcad that the surgery proceeded without the malfunctioning plates and guides.
Event or Problem Description
Plates and guides did not sit flush on patient anatomy.

• Brand Name: ACCUPLATE 3DTI
• Common Device Name: ACCUPLATE 3DTI PATIENT-SPECIFIC PLATE
• Manufacturer (Section D): MEDCAD; 501 s. second 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. second ave.; suite a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 20606280
• Report Number: 3009196021-2024-00010
• Device Sequence Number: 18028050
• Product Code: JEY
• UDI-Device Identifier: 00810007632476
• UDI-Public: (01)00810007632476(10240253GAL
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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
• Device Model Number: MC-3DT011
• Device Catalogue Number: MC-3DT011
• Device Lot Number: 240253GAL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 74 YR
• Patient Sex: Female