MAUDE Adverse Event Report: ULRICH GMBH AND CO. KG UCENTUM SCREW, POLYAXIAL, 5.5 DIA., 40MM LENGTH, PERFORATED; POLYAXIAL SCREW

Model Number	CS 3802-055-040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	11/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to user information.A pedicle screw broke after approximately 18 to 24 months of implantation.No further information is available at this time.

• Brand Name: UCENTUM SCREW, POLYAXIAL, 5.5 DIA., 40MM LENGTH, PERFORATED
• Common Device Name: POLYAXIAL SCREW
• Manufacturer (Section D): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, bw 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, bw ; GM
• Manufacturer Contact: andreas hilzenbecher ; buchbrunnenweg 12; ulm, bw 89081 ; GM 89081
• MDR Report Key: 21068841
• Report Number: 9612420-2025-00001
• Device Sequence Number: 11582998
• Product Code: NKB
• UDI-Device Identifier: 04052536078769
• UDI-Public: 4052536078769
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K123717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CS 3802-055-040
• Device Catalogue Number: CS 3802-055-040
• Device Lot Number: U036679
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 68 KG