MAUDE Adverse Event Report: ULRICH MEDICAL USA MOMENTUM MIS; MIS SCREW, POLYAXIAL, Ø 7.5MM, LENGTH 40MM, CANNULATED, FENNESTRATED

Model Number	UU091-11-7540
Medical Device Problem Codes	Fracture (1260); Solder Joint Fracture (2324)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The removeable tab on a mis polyaxial screw, broke in the wrong location.One side post remained longer than intended.The surgeon was unaware of the potential problem.Post operative revision surgury was necessary when the patient complained about pain, which was due to the extended height of the tab.It was discovered the tab did not break in the region it was supposed to.The surgeon reported the instrument necessary to break the tab correctly was available in the surgical set but was not used.

• Brand Name: MOMENTUM MIS
• Common Device Name: MIS SCREW, POLYAXIAL, Ø 7.5MM, LENGTH 40MM, CANNULATED, FENNESTRATED
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75074
• Manufacturer (Section G): PM MACHINE/DUKE MANUFACTURING; 38205 western pkwy; willoughby 44094
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074
• MDR Report Key: 18965232
• Report Number: 3005823819-2024-00004
• Device Sequence Number: 15445206
• Product Code: NKB
• UDI-Device Identifier: 00810076333137
• UDI-Public: 00810076333137
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UU091-11-7540
• 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: Not provided
• Initial Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 50 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 120 KG