MAUDE Adverse Event Report: ULRICH GMBH AND CO. KG NEON3; SCREW, CANNULATED, MEDIALLY PRE-ANGLED, DIAMETER 4.0MM, LENGTH 30MM,

Model Number	CS 3906-40-30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Polyaxial head of screw broke of postoperatively.

• Brand Name: NEON3
• Common Device Name: SCREW, CANNULATED, MEDIALLY PRE-ANGLED, DIAMETER 4.0MM, LENGTH 30MM,
• Manufacturer (Section D): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• MDR Report Key: 18221286
• Report Number: 3005823819-2023-00014
• Device Sequence Number: 20488780
• Product Code: NKG
• UDI-Device Identifier: 04052536084494
• UDI-Public: 4052536084494
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2023

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 3906-40-30
• Device Catalogue Number: CS 3906-40-30
• Device Lot Number: U035892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/23/2023
• Device Age: 1 YR
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• 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: 50 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 120 KG