MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X15 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

(b)(6) : disassembly.When user tried to remove the peek jaws, it caused a disassembly of the implant a second implant was opened, but when inserter was removed it caused a rotation of the implant.Both events are related to a user error.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.Date of report; description of event or problem; type of report ; follow up type; evaluation codes & additional narrative were updated.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, based on the product history records, and the recurrence of this type of event for this implant the likely cause of the event is mishandling r while removing peek jaws from the implant.It points out that the surgeon probably did not follow surgical technique.As described in surgical technique, "if the peek cartridge is difficult to extract, rotate one side of the cartridge 90° caudal, then remove with forceps.Repeat on the remaining side." however, for the lack of information received from the reporter this hypothesis could not be validated.The cause for the device disassembly is unknown.Requests for additional information did not receive a response.The investigation found no evidence to indicate a device issue.If additional information was received that allo to draw a conclusion on this event another report will be sent.

Event Description

Mobi-c p&f us : disassembly.When user tried to remove the peek jaws, it caused a disassembly of the implant a second implant was opened, but when inserter was removed it caused a rotation of the implant.Both events are related to a user error.Both disassembly happen in the same level c4-c5.This report is about the first case of disassembly.

• Brand Name: MOBI-C IMPLANT 13X15 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: 6827012
• MDR Text Key: 85158349
• Report Number: 3004788213-2017-00060
• 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: 06/28/2018

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: MB3355
• Device Lot Number: 5283082
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1