MAUDE Adverse Event Report: ULRICH MEDICAL USA MOMENTUM; LOCKING SCREW

Model Number	UU051-30-0000
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a case the set screws would not final tighten on the l5 pedicle screw.Upon examination, it was noticed that the set screws were stripped.There was no harm to the patient.It is unknown whether the tulip or set screws were stripped and explanted as no devices were returned.An mdr is being filed on both set screws and tulips.

• Brand Name: MOMENTUM
• Common Device Name: LOCKING SCREW
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75074
• 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 ; 4692380832
• MDR Report Key: 25479832
• Report Number: 3005823819-2026-00019
• Device Sequence Number: 14823153
• Product Code: NKB
• UDI-Device Identifier: 00814386024273
• UDI-Public: 00814386024273
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/11/2026

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: UU051-30-0000
• Device Catalogue Number: UU051-30-0000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female