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 off 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
• Manufacturer (Section G): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• Manufacturer Contact: andreas hilzenbecher ; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• MDR Report Key: 17400039
• Report Number: 9612420-2023-00001
• Device Sequence Number: 5931940
• Product Code: NKG
• UDI-Device Identifier: 04052536161171
• UDI-Public: 4052536161171
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2016
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 120 KG