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

Model Number UU051-00-6545

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 328302863
• Report Number: 3005823819-2023-00011
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00814386022873
• UDI-Public: 00814386022873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UU051-00-6545
• Device Catalogue Number: UU051-00-6545
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR