MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT 15X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3575

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Unspecified Infection (1930)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

The complaint is unrefuted for one (1) of one (1) mobi-c implant: 15x17 h5 us, for the failure of patient harm.A photo of the patient was provided for review, which documented the event.Potential cause: the cause of the patient harm cannot be determined at this time.The information provided did not lead to any conclusive evidence that the device caused the patient harm.Complaint history: there were zero (0) other complaints for similar events (non biocompatible) related to the same part number or any associated lot numbers in the 12 months leading up to the notification date through to the present.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions, recalls, or product holds.Device use and compatibility: this device is used for treatment.Reported event is not related to a combination of product lines, therefore, a compatibility review is not applicable.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that a patient has suspected infection after undergoing a mobi-c procedure.The surgeon noticed the patient's neck was red around the surgical incision.No further patient information is available.

• Brand Name: MOBI-C IMPLANT 15X17 H5 US
• Type of Device: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: florence maily ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300 ; 33382803
• MDR Report Key: 10906889
• MDR Text Key: 218574397
• Report Number: 3004788213-2020-00209
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)240701(10)5345902
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MB3575
• Device Lot Number: 5345902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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