MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X17 H6 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

Product was returned to manufacturer.A visual examination was performed, product was found compliant.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 cause for the event a surgeon error.As reported, surgeon turn the inserter in the wrong way to release the prosthesis.Indeed, as described in surgical technique, the inserter has to be turned clockwise to release the cartridge screw.He must have tried to remove peek parts without releasing the screw holding the jaws which caused the prosthesis to disassemble.The investigation found no evidence to indicate device issue.Root cause: surgeon didn't follow instruction for implant to release the cartridge.

Event Description

Mobi-c p and f us: disassembly.It was a cervecal two levels surgery.From information reported, an issue occurred at the level c-5-c6: the surgeon turned the ring the wrong way and removed the implant.The upper plate disengaged, so a new implant was opened.No delay of more than 30 min has been reported.Surgery was completed with a wider implant.No impact on patient.Attempts have been made and no further information was provided.

• Brand Name: MOBI-C IMPLANT 13X17 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
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7618163
• MDR Text Key: 111637594
• Report Number: 3004788213-2018-00209
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2018

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: 02/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3376
• Device Lot Number: 5261830
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 36 YR