MAUDE Adverse Event Report: ULRICH GMBH AND CO. KG NEON3; SCREW, 3.5MM DIA., 14MM LENGTH,

Model Number	CS 3902-35-14
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A pedicle screw broke during surgery; part of it had to be left in the patient.The result was a delay in the operating time.

• Brand Name: NEON3
• Common Device Name: SCREW, 3.5MM DIA., 14MM LENGTH,
• Manufacturer (Section D): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, bw 89081 ; GM 89081
• MDR Report Key: 22154028
• Report Number: 3005823819-2025-00010
• Device Sequence Number: 12717375
• Product Code: NKG
• UDI-Device Identifier: 04052536084197
• UDI-Public: 04052536084197
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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 3902-35-14
• Device Catalogue Number: CS 3902-35-14
• Device Lot Number: U044976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/01/2025
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 68 KG