MAUDE Adverse Event Report: ULRICH MEDICAL USA UNION MAX; HIGH ANGULATION PLATE, 2-LEVEL, 28MM

Model Number	UU201-02-0028
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was not experiencing any issues, but came in for standard post-op follow up.After the scan, the surgeon noticed that one of the screws was backing out.When asked, the surgeon thinks that he turned the locking cam but was uncertain.This was a malfunction, no serious injury.The screw was left in place no intervention or revision is needed at this time.If circumstances should change a follow up will be issued.

• Brand Name: UNION MAX
• Common Device Name: HIGH ANGULATION PLATE, 2-LEVEL, 28MM
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75048
• Manufacturer (Section G): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, bw 89081 ; GM 89081
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; 5742659601
• MDR Report Key: 20392087
• Report Number: 3005823819-2024-00020
• Device Sequence Number: 6652113
• Product Code: KWQ
• UDI-Device Identifier: 00810076334547
• UDI-Public: 00810076334547
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K240515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: UU201-02-0028
• Device Catalogue Number: UU201-02-0028
• Device Lot Number: CU17084
• 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: 09/06/2024
• Initial Report FDA Received Date: 10/07/2024
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic