MAUDE Adverse Event Report: ULRICH GMBH AND CO. KG NEON3; SCREW, LONG SHAFT, CANNULATED, DIAMETER 4.0MM, LENGTH 38MM,

Model Number	CS 3904-40-38
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Polyaxial head of screw broke of postoperatively.Patient will be revised in week 26.

• Brand Name: NEON3
• Common Device Name: SCREW, LONG SHAFT, CANNULATED, DIAMETER 4.0MM, LENGTH 38MM,
• Manufacturer (Section D): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• MDR Report Key: 17401275
• Report Number: 3005823819-2023-00005
• Device Sequence Number: 14941338
• Product Code: NKG
• UDI-Device Identifier: 04052536161171
• UDI-Public: 4052536161171
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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 3904-40-38
• Device Catalogue Number: CS 3904-40-38
• Device Lot Number: U011933
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2023
• Device Age: 7 YR
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 120 KG