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

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 SCREW, POLYAXIAL, 6.5 DIA., 50MM 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: 20140915
• Report Number: 9612420-2024-00008
• Device Sequence Number: 15319120
• Product Code: NKB
• UDI-Device Identifier: 04052536078844
• UDI-Public: 4052536078844
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 130 KG