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

Catalog Number	MB3575
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• MDR Report Key: 10906889
• Report Number: 3004788213-2020-00209
• Device Sequence Number: 14173521
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)240701(10)5345902
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Catalogue Number: MB3575
• Device Lot Number: 5345902
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other