MAUDE Adverse Event Report: MEDCAD ACCUPLAN; TITANIUM SURICAL GUIDE

Model Number	MC-KT011, MC-KT021
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Surgeon performed an additional surgery without using the guides, next day of intial surgery.
Event or Problem Description
Guides did not fit during the surgical procedure, revision surgery required.

• Brand Name: ACCUPLAN
• Common Device Name: TITANIUM SURICAL GUIDE
• Manufacturer (Section D): MEDCAD; 501 s 2nd ave.; suite a-1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 3401 technology dr.; plano TX 75074
• Manufacturer Contact: vishvani patel ; 501 s 2nd ave.; suite a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 24519487
• Report Number: 3009196021-2026-00004
• Device Sequence Number: 21263474
• Product Code: DZJ
• UDI-Device Identifier: 00810007631240
• UDI-Public: (01)00810007631240(10)252547BRO
• 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): 03/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC-KT011, MC-KT021
• Device Catalogue Number: MC-KT011, MC-KT021
• Device Lot Number: 252547BRO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2026
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female