MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X15 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.From information provided, based on the product history records, and the recurrence of this type of event for this implant, it is assessed that the event could be due surgeon error when choosing the size of implant.However, the description received did not allow to understand perfectly if the "undersized" implant was replaced by a different size of implant.The complaint issue cannot be clearly identified and surgeon error hypothesis cannot be validated.The cause for the device issue is unknown.The description received did not allow to understand perfectly the surgical steps involved.The investigation found no evidence to indicate a device issue.Root cause is unknown.Device not returned to manufacturer.

Event Description

Mobi-c p&f us: undersized.From information provided, "there was a size issue: implant was "undersized".Additional description on this issue was provided: surgeon inserted the implant "and it was undersized.Surgeon then removed it and replaced with appropriate sized implant." reporter also confirmed that the trial were used without any problem.Despite information provided by reporter, surgery was completed successfully with a device of the same size.Delay of 60 min has been reported to remove the implants and reimplant new one.No impact on the patient.Attempts have been made to clarify the fact that all the devices that were billed had the same size than the "undersized" one, but no further information has been provided.

• Brand Name: MOBI-C IMPLANT 15X15 H5 US
• Type of Device: CERVICAL DISK PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7812826
• MDR Text Key: 118124289
• Report Number: 3004788213-2018-00262
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5300177
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR