MAUDE Adverse Event Report: ULRICH MEDICAL USA MOMENTUM; SCREW, POLYAXIAL, DIAMETER 5.5MM, LENGTH 45MM, CANULATED, FENESTRATED

Model Number	UU051-01-5545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient complained of pain; after doing a cat scan the surgeon became concerned regarding the "weird presentation" of the screws and opted to perform a mini-revision on 3/20.During the case on 3/20 x3 total screws were broken, 2 5.5x45mm pedicle screws (broken at the tip) and a 9.0x90mm iliac screw (broken near the top of the screw but below the tulip head).Cement was not used when these screws were implanted and the tips of both pedicle screws were left in the patient as was the iliac screw.The pedicle screws had been in the patient since 2022 and the iliac screw had been in since 2021.There is no evidence to suggest that these screws were broken prior to their attempted removal on (b)(6) and the surgeon only performed this revision due to the patient complaining of pain and the presentation of the screws on the cat scan.

• Brand Name: MOMENTUM
• Common Device Name: SCREW, POLYAXIAL, DIAMETER 5.5MM, LENGTH 45MM, CANULATED, FENESTRATED
• 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, oh 44094 ; GM 44094
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074
• MDR Report Key: 21861971
• Report Number: 3005823819-2025-00008
• Device Sequence Number: 7767875
• Product Code: NKB
• UDI-Device Identifier: 00814386023177
• UDI-Public: 00814386023177
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 04/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: UU051-01-5545
• Device Lot Number: 8291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 120 KG