MAUDE Adverse Event Report: ulrich medical USA Cortium; Screw, Ø 3.5mm, length 14mm, high angulation

Model Number	UU071-10-3514
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Tulip disassociated from the polyaxial screw from the polyaxial screw head while the surgeon was implanting it.The screw was removed and replaced without incident.

• Brand Name: Cortium
• Common Device Name: Screw, Ø 3.5mm, length 14mm, high angulation
• Manufacturer (Section D): ulrich medical USA; 3700 east plano parkway; suite 200; plano TX 75074
• Manufacturer (Section G): ulrich GmbH smf Co. KG; buchbrunnenweg 12; ulm, bw 89091 DEU; GM 89091 DEU
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; +1(469)238-0832
• MDR Report Key: 50255633
• Report Number: 3005823819-2026-00027
• Device Sequence Number: 13293265
• 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: 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: UU071-10-3514
• Device Catalogue Number: UU071-10-3514
• Device Lot Number: U047477
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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: Female
• Patient Weight: 150 LB
• Patient Race: White