MAUDE Adverse Event Report: ULRICH MEDICAL USA MOMENTUM; SCREW, POLYAXIAL, 6.5MM DIAMETER, LENGTH 45MM, NON CANULATED

Model Number	UU051-00-6545
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	10/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tulip disassociated from the polyaxial screw head while in situ.The screw was being adjusted by the surgeon at the time of disassociation.The screw was removed without incident and there was a short delay in the procedure.

• Brand Name: MOMENTUM
• Common Device Name: SCREW, POLYAXIAL, 6.5MM DIAMETER, LENGTH 45MM, NON CANULATED
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano 75074
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; 4692380832
• MDR Report Key: 18150555
• Report Number: 3005823819-2023-00011
• Device Sequence Number: 20261008
• Product Code: NKB
• UDI-Device Identifier: 00814386022873
• UDI-Public: 00814386022873
• 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: 2023
• Device Explanted Year: 2023
• 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): 11/15/2023

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: UU051-00-6545
• Device Catalogue Number: UU051-00-6545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (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: Hospitalization
• Patient Age: 50 YR
• Patient Sex: Unknown