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

Model Number N/A

Device Problem Break (1069)

Patient Problems Pain (1994); Disability (2371); No Code Available (3191)

Event Date 07/23/2020

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 revision surgery was performed to remove a mobi-c device due to kyphosis, implant breakage, and pain.No further information is available.

Manufacturer Narrative

Information was entered into e4 in error; there are no changes from the initial submission.Added information to d8 and h6: component codes, type of investigation, investigation findings, and investigation conclusions.This follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is unrefuted for one (1) of one (1) mobi-c implant (pn unk) for the failure of device fracture leading to revision surgery.Medical records were not provided for review.Device evaluation: product was not returned and no photos were provided.Device evaluation could not be performed.Potential cause: root cause was unable to be determined as not enough information was provided and the product was not returned.Dhr review and related actions: dhr review was not performed since the lot number was not provided.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 revision surgery was performed to remove a mobi-c device due to kyphosis, implant breakage, and pain.No further information is available.

• 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, n/a 10300 ; FR 10300
• MDR Report Key: 11016110
• MDR Text Key: 221739499
• Report Number: 3004788213-2020-00229
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 59 YR