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

Catalog Number MB3XXX

Device Problems Mechanical Problem (1384); Malposition of Device (2616)

Patient Problems Pain (1994); Hernia (2240); Anxiety (2328); Depression (2361); Movement Disorder (4412); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported that as a result of a mobi-c device implanted in the incorrect position, a patient has experienced the following problems post-operatively: pain, disability, inability to move or function, hernia in the waist (causing separate surgery), device malfunction, stress, depression, anxiety, and fear.There are no indications that a revision surgery was performed.The patient described having a fusion device installed at c6/7, but there are no direct allegations against the fusion device.

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.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product not returned, photos not provided and x-rays not provided.Device evaluation unable to be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to operational factors, patient factors, or post-op care factors.Dhr review: dhr unable to be reviewed 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.

Event Description

It was reported that as a result of a mobi-c device implanted in the incorrect position, a patient has experienced the following problems postoperatively: pain, disability, inability to move or function, hernia in the waist (causing separate surgery), device malfunction, stress, depression, anxiety, and fear.There are no indications that a revision surgery was performed.The patient described having a fusion device installed at c6/7, but there are no direct allegations against the fusion device.

• Brand Name: IMPLANT MOBIC M ST, 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: 14136691
• MDR Text Key: 289450979
• Report Number: 3004788213-2022-00028
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 07/11/2022
• 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): Disability; Hospitalization; Required Intervention; Other
• Patient Sex: Female