MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; NEON SCREW, SELF-TAPPING, CANNULATED, 4.0MM LENGTH 30MM

Model Number	CS 1401-30T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Initial surgery (b)(6) 2020, complete instrumentation can be seen in the image made during the surgery.After the surgery patient had a good recovery.According to patient, restrictions were followed.On (b)(6) 2021, a fracture in neon was detected in mr.Patient is well, waiting to know the next steps.Report 1 of 2.

• Brand Name: NEON3
• Common Device Name: NEON SCREW, SELF-TAPPING, CANNULATED, 4.0MM LENGTH 30MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & 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: 12984407
• Report Number: 9612420-2021-00014
• Device Sequence Number: 20171489
• Product Code: NKG
• UDI-Device Identifier: 04052536002863
• UDI-Public: 04052536002863
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

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
• Device Model Number: CS 1401-30T
• Device Catalogue Number: CS 1401-30T
• Device Lot Number: WSA12651810
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2005
• 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: Hospitalization
• Patient Sex: Unknown