MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; SCREW, Ø 3.5 MM, LENGTH 16 MM

Model Number	CS 3902-35-16
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Post op x-rays revealed two screws were backing out.A revision was scheduled and done on (b)(6) 2020 and other issues occurred during the revision.Report 2 of 5.

• Brand Name: NEON3
• Common Device Name: SCREW, Ø 3.5 MM, LENGTH 16 MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 9897261
• Report Number: 9612420-2020-00005
• Device Sequence Number: 2788869
• Product Code: KWP
• UDI-Device Identifier: 04052536084203
• UDI-Public: 4052536084203
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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 3902-35-16
• Device Catalogue Number: CS 3902-35-16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 10/29/2021
• 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
• Patient Age: 69 YR