MAUDE Adverse Event Report: LDR MÉDICAL MOBIC NO TOUCH IMPLANT HOLDER; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); Positioning Problem (3009)

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

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

Several attempts were made to collect additional information concerning the inserter, such as the serial and lot number, used during the surgery.Yet, no answer was received.Therefore, no information concerning the product was reported.The review of the device history records and traceability could not be performed.Though it is written in the complaint report that the product was send to the manufacturer for evaluation as confirmed by the reporter, the product was not returned to the manufacturer.The product location is unknown.Therefore, no product evaluation could be performed.From the information provided based on the complaint report and the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.The review of the device history record and trackability of the related implant reveal no deviation to specification that may have impacted this event.The fact that the word "up" was not all the way visible, as reported on the complaint report , clearly means, as explained in the surgical technique, that the contact of the jaws with the implant holder was not successfully completed.This is the reason why the implant was still loose on the implant holder.It is stated in the surgical technique that visual control of contact between the implant and implant holder can be conducted using the window on the implant holder, the word "up", indicating the top of the prosthesis, becomes completely visible when the correct position is obtained.Yet, it is highlighted to take care to stop threading as soon as full contact is achieved in order to avoid premature opening of the peek cartridge and releasing the implant (step 9: mobi-c insertion).However , regarding the lack of available information and the absence of instrument analysis , mishandling during assembly hypothesis cannot be validated.Investigation found no evidence on a device issue.The exact root cause of this event remain undetermined with hypothesis of a user error during implant positioning on the inserter.If additional informations were received that allow to draw a conclusion for this case.Another report will be sent.

Event Description

Mobi-c inserter assembly difficulty.It was reported on the complaint report on (b)(6) 2017 that once the inserter was put together and the cervical disc was loaded, the implant was still loose and the word "up" was not all the way visible.Mobi-c inserter could not fully load the implant, when trying to remove to load onto the other (back-up) inserter, implant fell apart.The surgery was delayed 5 minutes.No impact on patient state of health was reported.The surgery was performed at the level c6-7.The surgery was completed with another device of another size (13*17 h7).It was reported that it was an equipment failure not implant failure.It was reported on the sales order, received on (b)(6) 2018 that a poor inserter assembly broke the cage, reference (b)(4) and lot 5279580.The implant was replaced by another implant of a different size, as reported on the sales order , reference (b)(4) and lot 5266950.Additional information received on (b)(6) 2018: the surgical guide was followed and the stop was set to zero.The reporter confirmed that all of the ldr trays were returned after use because trays were not kept at the facility.The reporter would not have any way of looking up or tracing the inserter for information.The implants and trays were sent in a couple of days in advance and unused implants and the trays were returned the following day.No additional information will be received from the reporter.

• Brand Name: MOBIC NO TOUCH IMPLANT HOLDER
• 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: 8115838
• MDR Text Key: 129889430
• Report Number: 3004788213-2018-00402
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MB9001R
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 41 YR