MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Detachment Of Device Component (1104); Disconnection (1171); Device Handling Problem (3265)

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

Event Type  Injury  

Manufacturer Narrative

The product wasn't returned , the batch number is unknown.Which prevent from reviewing the device history records and traceability.More information was requested to the reporter, no answer until this day.Investigation still in progress conclusion is not yet available.The device wasn't returned.

Event Description

Mobi-c p&f us : disassembled during insertion.The only information provided " the peek cartridge come loose during insertion and them implant came off , an new implant was opened".No sufficient informations about the case.No informations about lot number associated with the device.Information was requested to the reporter, investigation still in progress.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.The product was not returned to ldr.Therefore, no product evaluation could be performed.Several attempts were made to the reporter to collect additional information on this event.Yet, no answer was received.The review of the device history records and traceability could not be performed as no information concerning the implant lot number was reported.From information provided, the investigation found no evidence to indicate a device related issue.Indeed, it is possible that a poor loading was done as peek cartridge was reported as loose causing the implant disassembly.It is clearly stated in the surgical technique to take care to stop threading as soon as full contact is achieved to avoid premature opening of the peek cartridge and releasing the implant (step 9: mobi-c insertion).Moreover, visual control of contact can be confirmed using the window on the implant inserter.The word up, indicating the top of the device, becomes completely visible when the correct position is obtained (step 9: mobi-c insertion).Yet, the lack of information received, especially concerning the product information, and the absence of product return and evaluation prevent from validating the root cause of the complaint.The root cause is undetermined with the most likely hypothesis of user error during implant loading on inserter.If additional information is received that allows to confirm the conclusion, another report will be sent.

Event Description

Mobi-c p&f us : disassembled during insertion.The only information provided for this case : the peek cartridge come loose during insertion and then implant came off , an new implant was opened.No known impact on patient or surgery complication.No informations about lot number associated with the device severals attempts were performed to collect additional informations on this case.No answer received.

• Brand Name: MOBI-C IMPLANT 15X17 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
• MDR Report Key: 7620527
• MDR Text Key: 111741244
• Report Number: 3004788213-2018-00216
• 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
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• 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: MB3575
• Device Lot Number: NO INFORMATION
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1