MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X15 H5 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 07/28/2017

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Mobi-c p&f us: disassembly.Surgeon tried to disengage the inserter from the implant after insertion into disc space, but didn't unscrew completely implant from inserter causing a disassembly.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-conformance 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 likely cause of the event is a lack a preparation of disc space.Indeed, it shows that the surgeon hasn't completed discectomy properly like described in the surgical technique.This lack of preparation forced him to remove the device and the disassembly happened.Despite attempts, no details on movements done while removing device were provided.The investigation found no evidence to indicate device issue.Root cause : user error (instruction was not followed).

Event Description

Mobi-c p&f us : disassembly.From information reported , "surgeon inserted the device into disc space, but "did not disengage the inserter because he wanted to do more work in the disc space.He tried to remove the implant still attached to the inserter and it came apart." additional information was received : reporter don't have information on the reason why surgeon had to do more work on the disc space.He does remember that the surgeon used the trial.But he doesn't remember about distraction applied before removing the device, about resistance, rotation or angle, and about implant teeth being in vertebrae.

• Brand Name: MOBI-C IMPLANT 15X15 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: 6829955
• MDR Text Key: 84134402
• Report Number: 3004788213-2017-00063
• 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: 05/25/2018

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: 12/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5283083
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 03/30/2018
• Supplement Dates FDA Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 62 YR