MAUDE Adverse Event Report: MEDCAD ACCUPLAN; TITANIUM SURGICAL GUIDES

Model Number	MC-KT011
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Titanium mandible and fossa guides did not fit.

• Brand Name: ACCUPLAN
• Common Device Name: TITANIUM SURGICAL GUIDES
• 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: 24444608
• Report Number: 3009196021-2026-00003
• Device Sequence Number: 16045503
• Product Code: DZJ
• UDI-Device Identifier: 00810007631240
• UDI-Public: (01)00810007631240(10)252035GON
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/24/2026

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: MC-KT011
• Device Catalogue Number: MC-KT011
• Device Lot Number: 252035GON
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2026
• 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: 44 YR
• Patient Sex: Female