MAUDE Adverse Event Report: ULRICH MEDICAL GMBH & CO. KG NEON3; SCREW

Model Number	CS 3906-40-34
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Post-operative screw breakage.Report 2 of 2.

• Brand Name: NEON3
• Common Device Name: SCREW
• Manufacturer (Section D): ULRICH MEDICAL GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 12068816
• Report Number: 9612420-2021-00011
• Device Sequence Number: 3959281
• Product Code: KWP
• UDI-Device Identifier: 04052536084517
• UDI-Public: 04052536084517
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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 3906-40-34
• Device Catalogue Number: CS 3906-40-34
• Device Lot Number: U027478
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/25/2021
• 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: Required Intervention