MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X19 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

Device not received yet by manufacturer.

Event Description

Mobi-c p&f us : disassembly.Disassembly was directly reported as user error : "scrub tech got over confident and tightened implant too far onto the inserter causing the holding mechanism to come apart"¨ procedure successfully completed with another implant.There was no impact to the patient.Waiting for product return.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.

Manufacturer Narrative

This medwatch is submitted to give the result of the investigation of this complaint.From information provided, based on the product history records, and the recurrence of this type of event for this implant, the root 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.Device was not returned.

Event Description

Mobi-c p&f us : disassembly.

• Brand Name: MOBI-C IMPLANT 15X19 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: 6971172
• MDR Text Key: 90042340
• Report Number: 3004788213-2017-00156
• 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: 05/11/2018

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: 02/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3595
• Device Lot Number: 5285540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/24/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1