MAUDE Adverse Event Report: ULRICH MEDICAL USA UNION MAX; HIGH ANGULATION PLATE, 1-LEVEL, 13MM

Model Number	UU201-01-0013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the case the surgeon was turning the cam to cover the screw heads and the cam disassociated from the plate.The plate was replaced with a new one.The plate has not yet been returned to the company.There was no harm to the patient.

• Brand Name: UNION MAX
• Common Device Name: HIGH ANGULATION PLATE, 1-LEVEL, 13MM
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75048
• Manufacturer (Section G): CURITEVA MEDICAL; 25127 will mccomb dr; tanner AL 35671
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; 5742659601
• MDR Report Key: 24568899
• Report Number: 3005823819-2026-00005
• Device Sequence Number: 15854609
• Product Code: KWQ
• UDI-Device Identifier: 00810076334400
• UDI-Public: 00810076334400
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: UU201-01-0013
• Device Catalogue Number: UU201-01-0013
• Device Lot Number: CU17072-R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2024
• 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: 50 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic