MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT M < STANDARD > 15X17 H6 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 07/20/2017

Event Type  Injury  

Manufacturer Narrative

Discarded at hospital.

Event Description

The mobi-c implant cartridge came apart when the tech handed device to surgeon.Surgery was performed successfully with a new implant.Event reported as user error.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.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, the cause for the event is an excessive screwing while loading of prosthesis on inserter.Indeed, overtightening the inner rod that secures the implant-locking nut to the implant inserter will unscrew the locking nut from the peek holder and disassemble the device.The mobi-c surgical technique warns to stop threading (the inner rod) as soon as full contact is achieved in order to avoid opening the disposable implant holder and releasing the implant.The investigation found no evidence to indicate device issue.Root cause : user error (instruction was not followed during implant assembly on the inserter).

• Brand Name: MOBI-C IMPLANT M < STANDARD > 15X17 H6 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.; 5, rue de berlin; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6860957
• MDR Text Key: 86438070
• Report Number: 3004788213-2017-00085
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3576
• Device Lot Number: 5277000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2016
• 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: 39 YR