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

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	11/22/2024
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
• Common Device Name: POLYAXIAL SCREW, 5.5MM DIA. 40MM LENGTH
• Manufacturer (Section D): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, bw 89081 ; GM 89081
• MDR Report Key: 21072197
• Report Number: 3005823819-2025-00002
• Device Sequence Number: 18242395
• Product Code: NKG
• UDI-Device Identifier: 04052536078769
• UDI-Public: 4052536078769
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/20/2024
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 68 KG