MAUDE Adverse Event Report: ULRICH MEDICAL USA CORTIUM; THORACIC SCREW, DIA 3,5 MM, LENGTH 14 HIGH ANGULATION HEAD

Model Number	UU071-10-3514
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery the tulip head dissociated from the screw tail.The surgeon does not tap the preparation hole prior to driving the screws nor uses the tissue sleeve.Not using the tissue sleeve caused excessive pressure to the tulip head when pressure was applied to the screwdriver.This caused the tulip head to dissociate from the screw tail.

• Brand Name: CORTIUM
• Common Device Name: THORACIC SCREW, DIA 3,5 MM, LENGTH 14 HIGH ANGULATION HEAD
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75074
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, bw 89081 ; GM 89081
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; 4692380832
• MDR Report Key: 23382959
• Report Number: 3005823819-2025-00012
• Device Sequence Number: 8689771
• Product Code: NKG
• UDI-Device Identifier: 00814386026352
• UDI-Public: 00814386026352
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230614
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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: UU071-10-3514
• Device Catalogue Number: UU071-10-3514
• Device Lot Number: U047477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male