MAUDE Adverse Event Report: ulrich medical USA Cortium; Screw, Ø 4.0mm, length 22mm, high angulation

Model Number	UU071-10-4022
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon was reviewing the x-rays for a patient that he had done surgery on, on 8/4 when he saw that two screws needed to be repositioned because he did not like their positioning.The patient was not complaining of pain or any issues.After bringing the patient back in to revise the construct due to the positioning, he disassembled the screws as the tulip heads had come detached from the shaft.Surgeon was able to remove the screws successfully.

• Brand Name: Cortium
• Common Device Name: Screw, Ø 4.0mm, length 22mm, high angulation
• Manufacturer (Section D): ulrich medical USA; 3700 e 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 e. plano parkway; suite 200; plano, TX 75074 ; +1(469)238-0832
• MDR Report Key: 50256290
• Report Number: 3005823819-2026-00029
• Device Sequence Number: 18809519
• Product Code: NKG
• UDI-Device Identifier: 00814386026550
• UDI-Public: 00814386026550
• 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: 2026
• Device Explanted Year: 2026
• 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): 08/14/2026

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: UU071-10-4022
• Device Catalogue Number: UU071-10-4022
• Device Lot Number: U043709
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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: Hospitalization
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 150 LB