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

Model Number N/A

Device Problems Disassembly (1168); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

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

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Mobi-c p&f us : disassembly.The upper end plate of the disc somehow seemed to disassemble upon implantation and twisted.When the surgeon took the inserted off the peek was separated as well.Thought of the reporter is that the surgical tech may have overtightened the implant upon attaching to the inserter, hence loosening it.Disc space was not under distraction.Probable cause is user error.Surgery complete with another device not from the same size.Disassembled implant discarded.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

Product was not returned to the manufacturer.It was scrapped by the hospital.No delay of the surgery superior to 30 min was reported.No impact on patient.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.According to available data, investigation determined probable cause is related to an excess if screwing during loading of the prothesis on inserter.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 : fail to follow instruction during loading the implant on inserter.

Event Description

Mobi-c p&f us : disassembly.

• 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: florence chapaud ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3310648075
• MDR Report Key: 6900025
• MDR Text Key: 89386989
• Report Number: 3004788213-2017-00109
• 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: 02/19/2018

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: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5280105
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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: 54 YR
• Patient Weight: 64