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

Model Number UU091-11-7540

Device Problems Fracture (1260); Solder Joint Fracture (2324)

Patient Problem Failure of Implant (1924)

Event Date 10/23/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 338432619
• Report Number: 3005823819-2024-00004
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00810076333137
• UDI-Public: 00810076333137
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UU091-11-7540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 120 KG