MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; OCCIPITAL LATE, MIDLINE

Model Number	CS 3913-08
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ulrich medical gmbh (manufacturer) is submitting this report for both ulrich medical gmbh and ulrich medical usa (importer).Exemption # e2014011.
Event or Problem Description
The surgeon was not able to fixate the plate in its original positioning using the driver and had to remove it along with the screws and rod used and reposition it.Once the plate was repositioned/rotated and the surgeon was able to fixate it.

• Brand Name: NEON3
• Common Device Name: OCCIPITAL LATE, MIDLINE
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 8420548
• Report Number: 9612420-2019-00005
• Device Sequence Number: 13965919
• Product Code: NKG
• UDI-Device Identifier: 04052536170043
• UDI-Public: 4052536170043
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2019
• Report Date (Section F): 03/13/2019

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 3913-08
• Device Catalogue Number: CS 3913-08
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/14/2019
• 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: 53 YR