MAUDE Adverse Event Report: KLS-MARTIN L.P. LEVEL ONE NEURO; PLATE, BONE

Model Number 25-010-12-09

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Expulsion (2933)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 05/09/2023

Event Type  malfunction  

Event Description

On investigation we noted that there was a free-floating screw.As well as a fracture of the inferior aspect of the mesh along the left side.There was no evidence of any defects and the screw backed out of the cartilage.

• Brand Name: LEVEL ONE NEURO
• Type of Device: PLATE, BONE
• Manufacturer (Section D): KLS-MARTIN L.P.; 11201 saint johns industrial pkwy s; jacksonville FL 32246
• MDR Report Key: 17049878
• MDR Text Key: 316420713
• Report Number: 17049878
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2023,05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 25-010-12-09
• Device Catalogue Number: 250101209
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1