MAUDE Adverse Event Report: LDR MÉDICAL CLOSED CERVICAL CAGE 14X15.5 H6MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number MC322P

Device Problem Biocompatibility (2886)

Patient Problems Inflammation (1932); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3004788213-2023-00048 through 3004788213-2023-00051.

Event Description

A patient reported inflammation and chronic pain due to the metals or plastic components in two mc+ cages and plates.The constructs remain implanted.This is report three of four for this event.

• Brand Name: CLOSED CERVICAL CAGE 14X15.5 H6MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16973584
• MDR Text Key: 315662482
• Report Number: 3004788213-2023-00050
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 03662663021432
• UDI-Public: (01)03662663021432(10)20574R253
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC322P
• Device Lot Number: 20574R253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• 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): Other