MAUDE Adverse Event Report: ULRICH MEDICAL GMBH & CO. KG NEON3; SCREW, 3.5MM, LENGTH 12MM

Model Number	CS 3902-35-12
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Screw stripped during implantation and was removed and replaced.

• Brand Name: NEON3
• Common Device Name: SCREW, 3.5MM, LENGTH 12MM
• Manufacturer (Section D): ULRICH MEDICAL GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 11942648
• Report Number: 9612420-2021-00008
• Device Sequence Number: 4227089
• Product Code: NKG
• UDI-Device Identifier: 04052536084180
• UDI-Public: 04052536084180
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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
• Operator of Device: No Information
• Device Model Number: CS 3902-35-12
• Device Catalogue Number: CS 3902-35-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/04/2021
• 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: 57 YR