MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X19 H6 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 02/16/2018

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.Request for additional information on the instruments used for the surgery have been requested.Investigation is in progress.Device retained by the hospital.

Event Description

Mobi-c p&f us : disassembly.Provided description of the event " implant disengaged from the peek holder prior to implantation and fell to the ground." update (b)(6) 2018 : surgical technique was followed while loading implant on inserter.

Manufacturer Narrative

This medwatch is submitted to send the results of the investigation of this complaint.Product was not received at ldr medical, no visual examination could be done the review of the device history records did not reveal any non-conformance's to specifications or deviations in procedures that might have contributed to the reported event.Attempts were also made to collect additional information on the inserter used during surgery.No answer was received.From information provided, based on the product history records, the evaluation of the recurrence of this type of event for this implant shows no evidence on product issue.In addition, the lack of provided information of the event context prevents having a conclusive investigation.The root cause is considered undetermined an hypothesis acn explain this event as implant was overtightened on the inserter , however, the description received did not allow to understand perfectly if the surgical steps were followed or not.This hypothesis could be validated.If additional information were received that may impact the conclusion of this investigation another report will be sent.

Event Description

Mobi-c p&f us : disassembly provided description of the event , the implant disengaged from the peek holder prior to implantation and fell to the ground.Update (b)(6) 2018 : surgical technique was followed while loading implant on inserter.Bsed on the complaint report , there was no patient impact the surgery was delayed about 2 min surgery was completed with the same size prothesis.Additional information received on march 2018 , the reporter mentioned that the scrub tech probably changed the inserter to complete surgery , however he's not sure about this informations.Attempt were made to collect information on the inserter.No answer received the prothesis was not returned to manufacturer as kept by the hospital.

• Brand Name: MOBI-C IMPLANT 15X19 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
• MDR Report Key: 7381395
• MDR Text Key: 103818606
• Report Number: 3004788213-2018-00092
• 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: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: N/A
• Device Catalogue Number: MB3596
• Device Lot Number: 5237869
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 40 YR