MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT UNK SIZE; MOBI-C CERVICAL DISC PROSTHESIS

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Separation (4044)

Patient Problems Irritability (2421); Neck Pain (2433)

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 that a c6-7 implantation was performed without discectomy or foraminotomy.A large bone spur and the original collapsed disc were also left in the patient at the time of implantation.Eight months later the patient experienced radiculopathy and neck pain.A revision surgery was completed to remove the implant, bone spur, and old disk material.The patient underwent triple fusion.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is unrefuted for one mobi-c implant for the failure of patient pain leading to revision surgery.Medical records were not provided for review.Device evaluation: product was not returned and medical records were not provided for review, so a device evaluation could not be performed.Potential cause: root cause was unable to be determined as the product was not returned and medical records were not provided for review.Dhr review : dhr was not reviewed as lot number is not known.Device use: this device is used for treatment.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 c6-7 implantation was performed without discectomy or foraminotomy.A large bone spur and the original collapsed disc were also left in the patient at the time of implantation.Eight months later the patient experienced radiculopathy and neck pain.A revision surgery was completed to remove the implant, bone spur, and old disk material.The patient underwent triple fusion.

• Brand Name: MOBI-C IMPLANT UNK 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, n/a 10300 ; FR 10300
• MDR Report Key: 11664100
• MDR Text Key: 245961738
• Report Number: 3004788213-2021-00041
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MB3XXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention