MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X15 H6 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Disassembly (1168); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 10/20/2017

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.

Event Description

Mobi-c p and f us : disassembly.Disassembly occured when inserting implant into patient.Surgery was completed without issue with another implant.From additional description received, prosthesis could have been inserted with an angle.If it has been inserted with an angle.According to reporter, root cause is user error but he cannot be sure and won't have additional input to confirm this fact.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.Product received at ldr medical on the 22nd of january 2018 : visual & functional examination shows no particular issue.Marks on peek jaws are evidence of rotational movements.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 ("prosthesis could have been inserted with an angle"), based on the product history records, the evaluation of the received product (mark of rotation on jaws) and the recurrence of this type of event for this implant, it is assessed that the event could be due to mishandling when inserting or removing the prosthesis.It points out that the surgeon probably did not follow the instructions mentioned in the surgical techniques.As indicated in st : "during and after insertion, avoid lateral and rotational movements of the implant-to-peek cartridge assembly." the investigation found no evidence to indicate device issue.Root cause : surgeon didn't follow instruction during implant insertion.

• Brand Name: MOBI-C IMPLANT 13X15 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: 7036295
• MDR Text Key: 92157271
• Report Number: 3004788213-2017-00198
• 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: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5286949
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1