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

Model Number	CS 3902-35-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
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
Tulip head of screw broke during implantation.The screw was removed and replaced.

• Brand Name: NEON3
• Common Device Name: SCREW
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 7626972
• Report Number: 9612420-2018-00010
• Device Sequence Number: 11269915
• Product Code: NKG
• UDI-Device Identifier: 04052536084197
• UDI-Public: 4052536084197
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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 3902-35-14
• Device Catalogue Number: CS 3902-35-14
• Device Lot Number: U017936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/21/2018
• 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