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

Model Number CS 3901-01

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During the case, the screw's tulip was sheered off during final tightening.The rep believes this may have been caused by cross threading the locking screw.The screw was removed and replaced and the case was completed successfully.

• Brand Name: NEON3
• Type of Device: LOCKING SCREW
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; na; ulm, baden-württemberg 89081 ; GM 89081
• Manufacturer Contact: christoph ulrich ; buchbrunnenweg 12; na; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 8465475
• MDR Text Key: 140337332
• Report Number: 9612420-2019-00010
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 04052536084159
• UDI-Public: 4052536084159
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2019,03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS 3901-01
• Device Catalogue Number: CS 3901-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/05/2019
• Date Report to Manufacturer: 03/28/2019
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 63 YR