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

Model Number CS 3909-40-24

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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
• Type of Device: SCREW, CANNULATED, FAVORED ANGLE CRANIAL, 4.0MM, LENGTH 36MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• Manufacturer Contact: christoph ulrich ; buchrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 6851905
• MDR Text Key: 86148293
• Report Number: 9612420-2017-00023
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 04052536084463
• UDI-Public: 4052536084463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2017
• Device Age: 21 MO
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 08/11/2017
• Supplement Dates FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention