MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Break (1069); Disassembly (1168); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

Device not received yet.

Event Description

Mobi-c p&f us :disassembly.The implant fell apart while being put on inserter.Reporter believes the inserter was over-tightened and that was the cause of the issue.Procedure was completed successfully with another implant of the same size.No impact on patient.No delay.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.From description received, probable cause is user error.Product evaluation will be performed.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.From information provided, based on the product history records, the evaluation of the parts of the product and the recurrence of this type of event for this implant, the cause for the event is an excessive screwing while loading of prosthesis on inserter.Indeed, overtightening the inner rod that secures the implant-locking nut to the implant inserter will unscrew the locking nut from the peek holder and disassemble the device.The mobi-c surgical technique warns to stop threading (the inner rod) as soon as full contact is achieved in order to avoid opening the disposable implant holder and releasing the implant.The investigation found no evidence to indicate device issue.Root cause : user error (instruction was not followed).

Event Description

Product received on 24 th nov 2017, only the 2 enplates and core.Incomplete product was received on november 24th 2017.The two peek jaws and the screw were missing.There was no issue detected with the parts of the product that was received.

• Brand Name: MOBI-C IMPLANT 15X17 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
• 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.; 5, rue de berlin; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6989652
• MDR Text Key: 90627469
• Report Number: 3004788213-2017-00167
• 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,Followup
• Report Date: 04/16/2018

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: 03/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5286942
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/31/2017
• Supplement Dates Manufacturer Received: 11/24/2017
• Supplement Dates FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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: 42 YR