MAUDE Adverse Event Report: ULRICH GMBH AND CO. KG UCENTUM; POLYAXIAL SCREW, 6.5MM DIA. 50MM LENGTH

Model Number	CS 3802-065-050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to user information, the doctor conducted a revision surgery due to instability in the construct.During the operation it was found that one screw was broken.The broken screw was partially removed.The screw tip could not be removed and was left in the patient.

• Brand Name: UCENTUM
• Common Device Name: POLYAXIAL SCREW, 6.5MM DIA. 50MM LENGTH
• Manufacturer (Section D): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, bw 89081 ; GM 89081
• MDR Report Key: 20240486
• Report Number: 3005823819-2024-00019
• Device Sequence Number: 15494596
• Product Code: NKG
• UDI-Device Identifier: 04052536078844
• UDI-Public: 4052536078844
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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 3802-065-050
• Device Catalogue Number: CS 3802-065-050
• Device Lot Number: U035288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2024
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 130 KG