MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; SCREW, CANNULATED, FAVORED ANGLE CRANIAL, 4.0MM, LENGTH 36MM

Model Number	CS 3909-40-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/12/2017
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
Surgeon implanted a favored angle screw and was trying to insert the offset connector into the tulip portion of the screw.Force was applied to the offset connector, using a gun style reducer and the tulip portion of the screw broke.The screw was replaced with a new one and there were no issues.This resulted in a delay of surgery.

• Brand Name: NEON3
• Common Device Name: SCREW, CANNULATED, FAVORED ANGLE CRANIAL, 4.0MM, LENGTH 36MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 6851905
• Report Number: 9612420-2017-00023
• Device Sequence Number: 16273022
• Product Code: NKG
• UDI-Device Identifier: 04052536084463
• UDI-Public: 4052536084463
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K150650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: CS 3909-40-24
• Device Catalogue Number: CS 3909-40-24
• Device Lot Number: U011242
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2017
• Device Age: 21 MO
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 04/06/2018
• 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; Required Intervention