MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H6 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

Product was returned to manufacturer without decontamination form.Additional information are needed to initiate the product inspection process.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, the review of the case and the recurrence of this type of event for this implant, the likely 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).Additional information will be requested to initiate the product examination.If the product inspection add a value to this investigation conclusion , another report will be sent.

Event Description

Mobi-c p and f us : disassembled.As reported "a mobi-c implant came apart when it was loaded on inserter handle.A replacement implant was opened and utilized.It did not appear to involve the instrumentation or loading technique as the staff are very familiar with this product.The implant was loaded in the implant holder according to the guide.The users were well versed in loading this implant.It is possible the tech inadvertently over tightened when loading resulting in release of the implant." the surgery was completed successfully with another implant.No delay of more than 30 min has been reported.No impact on the patient.

• Brand Name: MOBI-C IMPLANT 15X17 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: 7805562
• MDR Text Key: 117897343
• Report Number: 3004788213-2018-00275
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2018

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: 04/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3576
• Device Lot Number: 5290549
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2017
• 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