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

Model Number N/A

Device Problems Material Separation (1562); Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

The review of the device history records and traceability 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, the review of the case during complaint meeting and the recurrence of this type of event for this implant, it was assessed that the cause of the event is a user error.The surgeon did not choose the right size of implant to begin with and when the surgeon tried to remove implant, it disassembled.This is confirmed by the fact that another device with a different size was used and worked/fitted perfectly.The investigation found no evidence to indicate device issue.Root cause : user error (instruction was not followed).Not returned because discarded.

Event Description

Mobi-c p&f us : superior plate was too posterior, then disassembled.According to the reporter : "(b)(6) placed implant 15x15x5 into the disc space.Upon xray he realized the implant superior plate was too posterior.He tried to level out the inferior plate to be parallel with the superior portion.The implant seemed loose while trying to tamp.So the implant he wanted to take out and try to replace again.The implant fell apart and was in 3 pieces.I said it's not recommended to implant again.So we chose another implant higher in height and shorter in depth.The new implant fit like a glove and was perfect." no delay.

• Brand Name: MOBI-C IMPLANT 15X15 H5 US
• Type of Device: CERVICAL DISC 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: 7959393
• MDR Text Key: 123493625
• Report Number: 3004788213-2018-00327
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5293833
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2017
• 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 Age: 46 YR