MAUDE Adverse Event Report: ULRICH GMBH AND CO. KG UCENTUM SCREW, POLYAXIAL, 6.5 DIA.,45MM LENGTH; POLYAXIAL SCREW

Model Number	CS 3804-065-045
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the report: during the implantation of a pedicle screw, an unnoticed dislocation of the inlay of the screw occurred without any application of force.A longitudinal rod was able to be properly blocked with the head screw without any problems.The dislocated part was not noticeable in the intraoperative image.The dislocated part of the screw could only be detected in the postoperative x-ray and the patient had to be revised.The patient insisted on retaining the screw after the revision surgery.

• Brand Name: UCENTUM SCREW, POLYAXIAL, 6.5 DIA.,45MM LENGTH
• 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: 20858238
• Report Number: 9612420-2024-00009
• Device Sequence Number: 18359056
• Product Code: NKB
• UDI-Device Identifier: 04052536079551
• UDI-Public: 04052536079551
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care 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 3804-065-045
• Device Catalogue Number: CS 3804-065-045
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 68 KG