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

Model Number N/A

Device Problem Break (1069)

Patient Problem Pain (1994)

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 patient experienced an event which they believe caused an implant failure.After the event the patient reports no movement at implantation level as well as a rapid severe increase of pain since the event.The patient inquired about physicians who can do revision surgeries.

Manufacturer Narrative

Corrections in b1, b5, and d5.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: device was not returned and photos were not provided, so a device evaluation could not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient factors, implanting next to prior fusions, or other operational factors.Dhr review: dhr review could not be performed as the 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 and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that a patient experienced pain and a lack of movement at the affected level after an event in which the patient believes the device broke.No further information was provided.

• Brand Name: MOBI-C IMPLANT, 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
• MDR Report Key: 11924565
• MDR Text Key: 254040001
• Report Number: 3004788213-2021-00060
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other