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

Model Number N/A

Device Problems Difficult to Remove (1528); Sticking (1597); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

Traceability reviewed and inspection record does not reveal any non compliance on this lot.Device not received yet by manufacturer.

Event Description

Mobi-c p&f us : cartridge would not release.Cartridge would not release off the implant with the grabbing device.The implant was eventually pulled out completely when trying to release the cartridge off of it.Surgery was completed with another device.No complication for patient.Additional information shows that the screw holding the jaws wasn't completely removed from the implant which must be the cause of the event.So surgical technique wasn't properly followed, cause of the event is user error.Device is returned to manufacturer but not received yet.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.It's considered as a product problem not an adverse event as mentioned in the first report.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 is a user error while removing the screw holding the two peek parts.Indeed, an incomplete unscrewing of the screw in peek cartridge would cause difficulty to disengage peek and or inserter.The mobi-c surgical technique warns to continue turning until the cartridge screw is completely released from peek cartridge.The investigation found no evidence to indicate device issue.Root cause: user error (instruction was not followed).Device not returned to manufacturer.

• 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
• 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: 6881877
• MDR Text Key: 86837495
• Report Number: 3004788213-2017-00100
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5284625
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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 Outcome(s): Other
• Patient Age: 53 YR