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

Model Number CS 3909-40-36

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Screw breakage.

• 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 ; 7319654 16
• MDR Report Key: 6708333
• MDR Text Key: 79886493
• Report Number: 9612420-2017-00019
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 04052536084739
• UDI-Public: 4052536084739
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CS 3909-40-36
• Device Catalogue Number: CS 3909-40-36
• Device Lot Number: U009625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2017
• Device Age: 21 MO
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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): Required Intervention