MAUDE Adverse Event Report: MEDCAD ACCUPLAN, ACCUPLATE 3DTI; TITANIUM HYBRID GUIDE AND 3D PRINTED TITANIUM LEFORT PLATE

Model Number	ZB-KT001-H, ZB-3DT011
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was confirmed by the sales rep.That the surgeon was able to complete the surgery with a slight delay and the misalignment did not affect the surgical outcome.No additional surgery required.
Event or Problem Description
The predictive holes didn't align with the plate.

• Brand Name: ACCUPLAN, ACCUPLATE 3DTI
• Common Device Name: TITANIUM HYBRID GUIDE AND 3D PRINTED TITANIUM LEFORT 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: 24558477
• Report Number: 3009196021-2026-00006
• Device Sequence Number: 18350103
• Product Code: DZJ
• UDI-Device Identifier: 00810007631219
• UDI-Public: (01)00810007631219(10)262733SIE
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K223024
• 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): 03/09/2026

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-H, ZB-3DT011
• Device Catalogue Number: ZB-KT001-H, ZB-3DT011
• Device Lot Number: 262733SIE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2026
• 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
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 54 KG