MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT M"STANDARD", UNKNOWN SIZE; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3XXX

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.

Event Description

It was reported the mobi-c device malfunctioned with no further information.After contacting the surgeon to request further information, the only information provided was that the patient will be revised to a fusion.

Event Description

It was reported the mobi-c device malfunctioned with no further information.After contacting the surgeon to request further information, the only information provided was that the patient will be revised to a fusion.

Manufacturer Narrative

Device evaluation: product was not returned and no photos were provided.A device evaluation was unable to be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to operational or patient factors.Dhr review : dhr review unable to be performed as lot number is not known.Device use : this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: MOBI-C IMPLANT M"STANDARD", UNKNOWN SIZE
• Type of Device: MOBI-C CERVICAL DISC PROSTHESIS
• 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: 15831029
• MDR Text Key: 303991820
• Report Number: 3004788213-2022-00108
• Device Sequence Number: 1
• Product Code: MJO
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MB3XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2022
• 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; Required Intervention